KCER: Kidney Community Emergency Response Coalition

Alerts & Recall Notifications

The kidney community uses a variety of products and resources to ensure the health and safety of patients and healthcare professionals. The United States Food and Drug Administration (FDA) issues alerts and notifications when these products and resources are unsafe or being recalled.

As directed by CMS, the KCER Coalition issues notices on FDA recalls via email and this website for the kidney community. To join the email list, please email NCC.

March 18, 2013

Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water,50ml For Injection Due To Mold Contamination

Audience: Health Professionals, Healthcare Facilities

Issue: Tinton Falls, NJ., Med Prep Consulting, Inc. is voluntarily recalling all lots of Magnesium Sulfate 2 grams in Dextrose 5% for Injection products compounded at its facility. The level of recall is to the user, that is, regional hospital pharmacies and related departments. The recall resulted from the pharmacy being notified by a Connecticut hospital, that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTION intravenous solution confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital. At this time a total of five (5) contaminated bags were discovered. At the time of this recall, there is no indication that the sterility of the magnesium sulfate products that the pharmacy dispensed to twelve other facilities was compromised. Nonetheless, in an abundance of caution, the pharmacy included all magnesium sulfate products in the voluntary recall. Administration of an intravenous product found to be contaminated with mold, could result in a fatal infection in broad array of patients. To date, no injuries or illnesses have been reported. The product is used for Magnesium electrolyte replacement for hospitalized patients. It is packaged in plastic infusion bags. It is distributed directly to regional hospital pharmacies.

Click here for additional details, recommendations and contact information.

March 18, 2013

Vascular Solutions Zerusa Ltd. Issues Recall of Guardian� II and Guardian� II NC Hemostasis Valves

Audience: Health Professionals, Healthcare Facilities

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February 27, 2013

Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication- FDA Suspends Pediatric Clinical Trials After Report Of Death

Audience: Health Professionals, Endocrinology, Pediatrics

Issue: FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of a 14-year-old patient in a trial. Posting this information does not mean that FDA has concluded whether or not Sensipar had a role in the patient�s death. This communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when our review is complete.

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February 25, 2013

OMONTYS®: Drug Recall Communication - Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS� (peginesatide) Injection.

Audience: Health Professionals, Patients, Home Care

Issue: Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited (Takeda) today have decided to voluntarily recall all lots of OMONTYS� (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. The companies have been working actively with the U.S. Food and Drug Administration (FDA) which has indicated its agreement with this decision. The companies have also issued a letter to health care professionals indicating that no new or existing patients should receive OMONTYS.

To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of OMONTYS. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. Since launch, more than 25,000 patients have received OMONTYS in the postmarketing setting. The rate of overall hypersensitivity reactions reported is approximately 0.2% with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization. The companies are actively investigating these cases. In the meantime, dialysis organizations are instructed to discontinue use. Customers will be provided instructions on how to return the product to the manufacturer for a refund. For customers with questions, please call 1-855-466-6689 [9:00 a.m. to 5:00 p.m. Eastern Standard Time, Monday through Friday].

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December 27, 2012

Heparin: Drug Safety Communication - Important change to heparin container labels to clearly state the total drug strength

Audience: Health Professionals, Patients, Home Care

Issue: FDA is notifying health care professionals, caregivers, and patients about a change to the container and carton labels for heparin products.

This label change will require manufacturers of Heparin Lock Flush Solution, USP and Heparin Sodium Injection, USP to clearly state the strength of the entire container of the medication followed by how much of the medication is in 1 milliliter (mL). These modifications will eliminate the need for health care professionals to calculate the total amount of heparin medication in a product containing more than 1 mL, thereby reducing the risk of miscalculations that may result in medication errors.

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November 20, 2012

HeartSine Samaritan Public Access Defibrillator 300/300P: Class I Recall - Device May Intermittently Turn On and Off

Audience: Risk Managers, Health Professionals

Issue: HeartSine notified customers that certain Samaritan 300/300P PAD devices have been found to intermittently turn on and off, which may eventually deplete the battery. In addition and separately, certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery, resulting in the device turning itself off. A device experiencing either condition could be unable to deliver therapy during a cardiac event. A list of serial numbers affected by this recall is provided.

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November 9, 2012

Baxter Healthcare Corp. Buretrol Solution Sets:
Class 1 Recall - May Not Function as Expected

Audience: Risk Managers

Issue: Baxter Healthcare Corp. (Baxter) has initiated a voluntary recall of its Buretrol Solution Sets because the ball-valve feature may not function as expected. Baxter has determined that the ball-valve component is allowing air to flow past the valve and enter the tubing once the pre-measured amount of fluids is completely administered to the patient. If the air is not removed, the air present in the tubing may enter the patient's vascular system potentially causing air in the bloodstream (an air embolism). This product may cause serious adverse health consequences, including death.

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November 2, 2012

FDA Safety Announcement: Ameridose, LLC: Recall of Unexpired Products in Circulation

Audience: Risk Manager, Healthcare Professionals

Issue: The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., is voluntarily recalling all of its unexpired products in circulation. The FDA is currently conducting an inspection of the Ameridose facility. Although this inspection is ongoing, the FDA's preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility. Use of non-sterile injectable products can represent a serious hazard to health that could lead to life-threatening injuries. Products from Ameridose can be identified by markings that indicate Ameridose by name or by its company logo. A complete list of all products subject to this recall can be accessed at www.ameridose.com.

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October 29, 2012

FDA Safety Announcement: Hospira Symbiq Infusion System Touchscreen: Class 1 Recall - May Not Respond to Selection
16026 Symbiq One Channel Infuser
16027 Symbiq Two Channel Infuser

Audience: Risk Manager, Nursing, Biomedical Engineering

The FDA notified healthcare professionals and provider organizations of the Class 1 recall of the Symbiq pump touchscreen. These devices may not respond to user selection, may experience a delayed response or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay or interruption in therapy or over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen before starting the infusion. All serial numbers for these models are affected by this recall.

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October 19, 2012

FDA Safety Announcement: FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised

Audience: Pharmacists, Risk Managers, Pain Medicine

CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate from one of the three implicated lots from NECC. The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections. Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues.

CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up.

There is now available a Patient Notification Letter on the FDA "Update on Fungal Meningitis" webpage under the "Related Information" section. This letter template is for healthcare professionals notifying patients administered a drug produced by the New England Compounding Center (NECC) that has been recalled.

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October 19, 2012

FDA Safety Announcement: Ventlab Corporation Issues Nationwide Recall of its Manual Resuscitators

Contact: Consumer: 1-800-593-5654

On July 11, 2012, Ventlab Corporation initiated a nationwide recall of 14,602 of its manual resuscitators. The manual resuscitators as listed have been found to potentially deliver little to no air/oxygen through the patient valve to the patient, which could result in life threatening health consequences that include hypoxia and hypoventilation.

End Users who have manual resuscitators at the lot numbers listed should stop using them and immediately contact Ventlab Corporation for further instructions on the return of these products.

Recalled manual resuscitators were manufactured and distributed nationwide to distributers that sold and distributed products to hospitals, clinics and EMS units from March 2012 to July 2012.

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October 17, 2012

FDA Safety Announcement: FDA MedWatch: Safety Information and Adverse Events Reporting

The MedWatch September 2012 Safety Labeling Changes posting includes 60 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The "Summary Page" provides a listing of drug names and safety labeling sections revised.

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October 16, 2012

FDA Safety Announcement: Fungal Meningitis Outbreak - Additional Patient Notification Advised

Audience: Pharmacists, Risk Managers, Pain Medicine

The FDA safety announcement, Fungal Meningitis Outbreak - Additional Patient Notification Advised, provides information related to a list of products including some that are used in the kidney community. The FDA previously issued guidance to medical professionals that all products distributed by the New England Compounding Center (NECC) should be retained, secured, and withheld from use.

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October 11, 2012

FDA Safety Announcement: Asahi Kasei, REXEED^TM - 15 SX, Hemodialyzer - Recall Class 2

Audience: Health Care Professionals and Consumers

Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the products, though there is no sufficient information to date to conclusively link these adverse events to the products.

Asahi Kasei Medical Co., LTD sent a Medical Device Recall letter on September 21, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm that they have no inventory and to forward the letter to all clinics who may have received the product requesting they check their stock and arrange for the return of any recalled product. Non-responding consignees will be contacted by telephone. For questions regarding this recall call Asaki Kasei Medical America, Inc. at 888-362-6105.

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October 10, 2012

FDA Safety Announcement: Asahi Kasei, REXEED^TM - 18 LX, Hemodialyzer - Recall Class 2

Audience: Health Care Professionals and Consumers

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August 23, 2012

FDA Safety Announcement: CareFusion 303, Alaris Pump Module, Model 8100: Class I Recall - Potential for Pump Malfunction to Stop Infusion

Audience: Risk Manager

FDA notified healthcare professionals of a Class I Recall of the CareFusion 303, Alaris Pump Module, Model 8100, due to a potential for the pump module door keypad overlay to become loose, peel away, or separate from the door assembly. This could cause a potential for fluid ingress which could lead to a keypad malfunction, causing the infusion to stop with alarm. When infusion stops, serious injury or death may result.

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August 3, 2012

FDA Safety Announcement: Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I Recall - System Errors May Cause Device Shutdown

Audience: Risk Manager, Biomedical Engineering

FDA notified healthcare professionals and medical care organizations of the Class 1 recall of all Model 4000 pumps with software Versions V1.0 and V1.1 due to system errors that can cause the Medfusion 4000 infusion pump to go into an alarm condition and stop running, resulting in a delay or an interruption of patient therapy. Delay or interruption of infusion therapy could result in serious injury and/or death.

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August 1, 2012

FDA Safety Announcement: B. Braun Infusomat Space Infusion System: Class I Recall - Potential for Breakage of Anti Free Flow Clip Catch

Audience: Risk Manager

FDA Notified healthcare professionals of a Class I Recall of the B. Braun Infusomat Space Infusion System, due to the potential for breakage of the anti free flow clip catch located inside the infusion pump door. Breakage may occur when the IV set anti free flow clip catch is inserted improperly into the pump and the pump door is forced closed. Misloading of the anti free flow clip catch may create the potential for free flow of medication. Free flow, especially of narrow therapeutic range drugs, can cause life-threatening effects and injuries. Affected pumps were distributed from November 6, 2008, to December 29, 2011. See the Recall Notice for a list of affected model numbers.

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August 1, 2012

FDA Safety Announcement: CareFusion Alaris PC Unit, Model 8015: Class I Recall - Error Code

Audience: Risk Manager, Critical Care Medicine

FDA notified healthcare professionals of a Class I Recall of the Alaris PC unit, model 8015. A component on the PC unit power supply board is causing an error code (120.4630): "System Error" or "Missing Battery Error" to occur. The error code is accompanied by both an audible alarm and a visual error message on the PC unit screen. If the error code occurs at start-up, the Alaris infusion pump cannot be programmed and this may cause a delay in patient therapy. If the error code occurs during infusion, the health care provider cannot make programming changes to current infusions, and this may result in serious injury and/or death to the patient.

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June 27, 2012

FDA Safety Announcement: Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate - Recall Class 1

The FDA has issued an updated notification for Health Care Professionals and Consumers on Naturalyte and Granuflo Acid Concentrate and for Naturalyte GranuFlo (powder) Acid Concentrate with specific serial numbers that were manufactured and distributed from January 2008 through June 2012.

The Naturalyte and Granuflo Dry Acid Concentrate are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates. This product may cause serious adverse health consequences, including death.

Consumers may contact the firm at 1-800-662-1237.

For additional details and contact information Click here.

June 26, 2012

FDA Alert: Cefepime: Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment

The FDA is notifying Health Professionals in Infectious Disease and Nephrology that there have been cases of a specific type of seizure called nonconvulsive status epilepticus associated with the use of cefepime, primarily in patients with renal impairment who did not receive appropriate dosage adjustments of cefepime. The Warnings and Precautions and Adverse Reactions sections of the cefepime label are being revised to highlight this risk.

Cases of nonconvulsive status epilepticus associated with cefepime are documented in the medical literature and have been identified in FDA's Adverse Event Reporting System (AERS) database. Most cases occurred in patients with renal impairment who did not receive appropriate dosage adjustment; however, some cases occurred in patients receiving dosage adjustment appropriate for their degree of renal impairment. In the majority of cases, the seizures were reversible and resolved after discontinuing cefepime and/or after hemodialysis. See the Drug Safety Communication for additional information.

Health care professionals should adjust the dosage of cefepime in patients with creatinine clearance less than or equal to 60 mL/min. If seizures associated with cefepime therapy occur, consider discontinuing cefepime or making appropriate dosage adjustments in patients with renal impairment.

Caregivers who notice symptoms of nonconvulsive status epilepticus in a patient receiving cefepime should seek medical attention right away. Symptoms of nonconvulsive status epilepticus could include altered mental status, confusion, and decreased responsiveness.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm.
Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch safety alert, including a link to the Recall Notice at: www.fda.gov.

June 22, 2012

FDA Alert: Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

The FDA is notifying Consumers and Healthcare Providers that Capacitor failure may result in a fire hazard and loss of supplemental oxygen. These products may cause serious adverse health consequences, including death. Affected products include serial numbers from 042-10000 through 102-09335. These oxygen concentrators were manufactured from January 1, 2004 to May 15, 2010. Oxygen concentrators are used to supply supplemental oxygen to patients within a home setting.

The firm sent its distributors a Field Correction notice May 1, 2012, asking distributors to contact customers and/or patients who brought these products. Consumers should notify your equipment provider if you have an affected product in your home or place of business. According to the firm, patients may continue to use the device while waiting for a replacement for the corrected component.

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm.
Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch safety alert, including a link to the Recall Notice at: www.fda.gov.

June 15, 2012

FDA Alert: Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall - Risk of Fire, Loss of Supplemental Oxygen

The FDA is notifying Risk Managers and Nurses regarding an Expanded Class I Recall-Serial numbers range from 700000 through 794213. All pumps serviced by SIGMA after September 21, 2010, or remediated as part of the initial recall notification, and all pumps manufactured after November 1, 2010, are not affected by this expanded recall. SIGMA expanded their recall to include additional affected units manufactured from January 18, 2005 through November 1, 2010, with the exception as noted above. These units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.

Originally Posted 11/14/10, the FDA notified healthcare professionals of the class 1 recall of the SIGMA Spectrum Infusion Pump Model 35700. These units may fail suddenly, causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.

The recalled pump is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. The recall was initiated September 15, 2010 and includes serial numbers from 706497 to 724065.

Sigma has instructed healthcare facilities to verify whether the serial numbers for their infusion pumps fall within the range of pumps being recalled and is requiring the return of the recalled devices. Sigma has instructed users to not use the infusion pumps on patient populations, including neonatal patients, where inaccurate flow, ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death.

[11/12/2010 - Recall Notice 1 - FDA]

[6/15/2012 - Recall Notice 2 - FDA]

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm.
Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch safety alert, including a link to the Recall Notice at: www.fda.gov.

May 25, 2012

FDA Alert: Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors

The FDA is notifying health care providers to consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates when determining the patients' dialysate prescription. The FDA received a complaint describing alkali dosing errors that occurred during hemodialysis using dialysate concentrates containing acetic acid and acetate. When metabolized, these potential sources of alkali can contribute to elevated bicarbonate levels in patients undergoing hemodialysis. This can contribute to metabolic alkalosis, which is a significant risk factor associated with cardiopulmonary arrest, low blood pressure, hypokalemia, hypoxemia, hypercapnia, and cardiac arrhythmia. Health care providers should review the dialysate acid concentrate labeling for the specific concentrate that they prescribe to determine the components that can contribute to the patient's overall bicarbonate levels. The levels of acetate, citrate and/or acetic acid vary by formulation and by manufacturer. Be aware that metabolic alkalosis (pre-dialysis serum bicarbonate levels > or = to 27 mEq/L) has been associated with a higher risk of death in hemodialysis patients. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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August 27, 2011

Recall Notice: H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel Recall - Inadequate Microbial Testing

On August 27, 2011, H & P Industries and the FDA issued a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased. It is advised that healthcare professionals and patients report any adverse health events related to use of this product to the FDA?s MedWatch Safety Information and Adverse Event Reporting System.

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August 3, 2011

Recall Notice: Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: Class I Recall

On August 3, 2011, the FDA notified healthcare professionals of a Class I recall of certain Arrow NextStep Antegrade Chronic Hemodialysis Catheters, due to reports of breakage and/or separation of the stylet. These products were distributed to medical facilities and physicians in California, Delaware, Florida, Michigan, North Carolina, and Tennessee. Listed below are the affected product and lot numbers which were manufactured between April 14, 2011 and May 9, 2011.

Product Number	Lot Number
CS-15192-IXM	RV1034909
CS-15232-IXM	RV1034911
CS-15272-IXM	RV1034912
CS-15312-IXM	RV1034913
CS-15422-IX	RV1034914
CS-15502-IX	RV1034915

The Arrow NextStep Antegrade Catheter is indicated for use in adult patients for attaining long-term vascular access for hemodialysis and apheresis. Chronic hemodialysis catheters are typically placed into a large vein in the patient's neck. Customers should check their stock, cease use and distribution, and quarantine all affected product. See the Recall Notice for additional information. For questions regarding this recall, contact Arrow International Inc. Customer Service at 1-(800)-233-3187.

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July 7, 2011

FDA Notice: Nulojix (belatacept) ? Risk Evaluation and Mitigation Strategy (REMS)

On July 7, 2011, Bristol-Myers Squibb (BMS) informed healthcare professionals about the REMS that is required for Nulojix to ensure that the benefits of Nulojix outweigh the risks of Post-transplant Lymphoproliferative Disorder (PTLD) and Progressive Multifocal Leukoencephalopathy (PML), both of which can be fatal. Patients treated with Nulojix are at an increased risk for developing PTLD, predominantly involving the Central Nervous System. PML has been reported in patients receiving Nulojix at higher than recommended doses as part of an immunosuppressant regimen. It is recommended that healthcare providers verify the patient?s Epstein-Barr virus status before initiating therapy with Nulojix. BMS established the ENLiST Registry to further evaluate the safety profile of Nulojix. BMS encourages provider participation in the ENLiST Registry.

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June 24, 2011

Recall Notice: Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendation

June 24, 2011 - The FDA is working to inform healthcare professionals that new modified recommendations for more conservative dosing of Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic kidney disease (CKD) have been approved in order to improve the safe use of these drugs. The FDA made these new recommendations because of data showing increased risks of cardiovascular events with ESAs in this patient population. The new dosing recommendations are based on clinical trials showing that using ESAs to target a hemoglobin level of greater than 11 g/dL in patients with CKD provides no additional benefit than lower target levels, and increases the risk of experiencing serious adverse cardiovascular events, such as heart attack or stroke.

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May 10, 2011

Recall Notice: Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall - Software Defect May Cancel Shock

On May 10, 2011, Defibtech, LLC a manufacturer of Automated External Defibrillators (AEDs) issued a recall of its Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. The company warned that AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient. AEDs are used on victims of sudden cardiac arrest when the patient is unconscious, unresponsive, and not breathing. To address this issue, Defibtech will provide customers with a free software upgrade. Because the conditions that may lead to a canceled shock occur rarely, it is recommended that customers keep their AEDs in service during the software upgrade process. Full instructions and recommendations are being mailed to affected customers. Defibtech is responsible for contacting all end users unless a distributor has agreed to contact their accounts directly regarding this field correction. Questions regarding this recall may be directed to Al Raebuck, Customer Service Manager, Defibtech at techsupport@defibtech.com, 1-877-453-4507 or 1-203-453-4507. Click here for more information.

May 6, 2011

Recall Notice: Weck Hem-o-Lok Ligating Clips: Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy

On May 6, 2011, The FDA notified health care providers that Weck Hem-o-Lok Ligating Clips should not be used for the ligation of the renal artery during a laparoscopic living-donor nephrectomy because of serious risks to the donor. There is the potential for the clips to become dislodged, which can lead to uncontrolled bleeding, additional surgery, or death of the donor. In 2006, the manufacturer added this contraindication to the Instructions for Use after receiving 15 reports of 12 injuries and three deaths which occurred between 2001 and 2005. Since the contraindication issued in 2006, there have been three more kidney deaths, all associated with the contraindicated use. The Weck Hem-o-Lok Ligating Clip is a V-shaped clip made from a non-absorbable material that comes in various sizes. It is used to permanently close bleeding vessels or tissue structures. See the FDA safety communication for a listing of affected model numbers, and recommendations for healthcare providers, hospital staff, and patients.

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May 3, 2011

Recall Notice: Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency

On May 3, 2011, Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets. Company product testing indicated that a tablet in this lot had a higher potency than anticipated. The affected lot number in the U.S. is 9H49374A with an expiration date of September 30, 2012. Any decrease of active ingredient in the mediation may increase the risk of clots which could lead to heart attack or stroke, and alternatively, if there is too much active ingredient, there is an increased risk of bleeding. It is recommended that patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affect lot and if so, should consult their physician for additional medical advice. For further information related to this recall contact: Stericycle, Inc. at (866) 918-8739.

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March 29, 2011

Recall Notice: Roche ACCU-CHEK FlexLink Plus Infusion Set: Class I Recall - Potential for Under-Delivery of Insulin

A Class I Recall has been issued for Roche ACCU-CHEK FlexLink Plus Infusion Sets. There is the potential for under-delivery of insulin due to a tube (cannula) which may become kinked or bent when inserting the ACCU-CHEK FlexLink Plus infusion set. If gone unnoticed, this can result in the under-delivery or no delivery of insulin. This can lead to elevated blood glucose levels (hyperglycemia). Hyperglycemia can lead to many serious health complications including death. Of important note, this recall only applies to the ACCU-CHEK FlexLink Plus infusion sets that were launched in November 2010. ACCU-CHEK Ultraflex, other Accu-Chek infusion sets or insulin pumps are not affected by this recall and can be continued as directed by a physician or other qualified healthcare provider. Roche requests that its consumers stop using the ACCU-CHEK FlexLink Plus infusion sets and return the unused products. Patients are encouraged to contact their health care providers or caregivers to determine if changes to their therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set.

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March 29, 2011

Recall Notice: Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A, D

Tested Samples of Soladek Vitamin Solution have been found to contain elevated levels of vitamin A and vitamin D that were many times the recommended daily allowance for these vitamins. The intake of excessively high levels of these vitamins poses a risk to human health. Symptoms of vitamin A toxicity include anemia, anorexia, alopecia, joint pain, bone weakness, bulging eyes, liver abnormalities, and birth defects. Symptoms of vitamin D toxicity include weakness, fatigue, headache, nausea, vomiting, diarrhea, changes in mental status, increased blood pressure, abnormal heart rate or rhythm, kidney damage, and coma. Soladek Vitamin Solution is marketed with claims that the product treats "hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy." The product is sold in a box labeled in Spanish and containing a vial of the solution. Those in possession of Soladek should stop using the product immediately. Any consumers who have been using Soladek and are experiencing any of the above symptoms should see a doctor immediately.

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March 18, 2011

Recall Notice: American Regent Injectable Products: Recall - Visible Particulates in Products

On March 18, 2010, American Regent, Inc. initiated a recall of certain injectable products manufactured by the company which have the potential for glass to flake from the product vial into the injection solution. The recalled products include:

[03/16/2011 - Press Release3, Dexamethasone Sodium Phosphate - American Regent]
[03/15/2011 - Press Release4, Bacteriostatic Sodium Chloride - American Regent]
[03/15/2011 - Press Release5, Concentrated Sodium Chloride - American Regent]
[02/04/2011 - Press Release6, Sodium Thiosulfate - American Regent]
[02/03/2011 - Press Release7, Potassium Phosphates - American Regent]

Previous, related product alerts:

[12/24/2010 - Dexamethasone Sodium Phosphate Injection8]
[12/29/2010 - Sodium Bicarbonate Injection9]

Glass delamination (separation) can occur with high pH solutions. Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics, and other healthcare facilities should not use recalled American Regent products. Recalled products should be immediately quarantines for return. Refer to the highlighted Press Releases above for specific lot numbers recalled. Click here for more information.

March 18, 2011

Recall Notice: H & P Industries Povidine Iodine Prep Pads: Recall - Potential Microbial Contamination Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources

On March 18, 2011, H&P Industries, Inc. initiated a voluntary recall of ALL LOTS of Povidine Prep Pads manufactured by their company, but which are privately labeled for many accounts. Recent testing has shown of Elizabethkingia meningoseptica on the pads. Use of contaminated Povidine Prep Pads could lead to life threatening infections, especially in at risk populations, including neonates, immune suppressed pateints, and surgical patients. Providine Iodine Prep Pads are used to prevent infection in minor cuts, scrapes, and burns, and are labeled as an antiseptic for preparation of the skin prior to surgery. The pads were distributed nationwide to healthcare customers ans are packaged in individual packets in a box of 100 packets Healthcare organizations should contat H&P Industries at (262) 538-2900 to arrange a return. Any consumer in possession of these pads should not use the product.

Click here for more information.

February 1, 2011

Recall Notice: B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall - Hardware May Become Unresponsive

On February 1, 2011, B. Braun Medical Inc. and the FDA issued a Class 1 Recall of its Outlook 400ES Safety Infusion System, Model# 621-400ES. Infusions systems upgraded with the Motorola compact flash hardware and supporting software, when used in a network environment that utilizes Temporal Key Integrity Protocol (TKIP) authentication, can potentially induce a memory leak that can cause the Management Processor to become non-responsive. This causes normal operation to stop, which is signaled by an audible backup alarm indicating that the pump is not delivering the medicine. It is encouraged that customers deactivate the wireless communication on their pumps and return them to the manufacturer. Any questions can be directed to B. Braun Medical Inc. at (972) 245-2243.

Click here for more information.

January 20, 2011

Recall Notice: Fresenius Medical Care - CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for use with the Blood Volume Monitor

On January 14, 2011, Fresenius Medical Care North America announced a voluntary recall notice of CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors (Part Numbers 03-2695-9 and 03-2795-7) for use with the Blood Volume Monitor (BVM), due to reports of arterial line kinks. These kinks may manifest as arterial pressure alarms or be mistaken as access problems. There is also the potential for kinking to cause hemolysis can result in serious injury or death. The recall includes the following part numbers and lot numbers which were sold in the U.S. and Canada.

Part Number: 03-2695-9
Lot Numbers: 10HR01065, 10HR01083, 10HR01197, 10HR01259, 10JR01019, 10JR01031, 10JR01040, 10JR01058, 10JR01067, 10JR01077, 10JR01239, 10LR01041, 10LR01053, 10LR01061, 10LR01070, 10LR01102,10LR01111, 10LR01123, 10LR01269, 10LR01282, 10LR01283, 10LR01284, 10LR01285, 10NR01020, 10NR01031, 10NR01041, 10NR01050, 10NR01146, 10NR01157, 10NR01169, 10NR01180

Part Number: 03-2795-7
Lot Numbers: 09JR01174, 09JR01229, 09NR01139, 10KR01801

Customers who have the affected lots of CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for use with the BVM which are being recalled should discontinue their use immediately and return product to Fresenius Medical Care. Clinic Managers, Unit Administrators and/or distributors with questions may contact Fresenius Medical Care Customer Service Team at 1-800-323-5188 in USA (7am-6pm CST, 5 days per week, with after-hours emergency support) and 1-888-709-4411 in Canada.

In addition, it is advised that healthcare professionals and patients report any adverse health events related to use of this product to the FDA?s MedWatch Safety Information and Adverse Event Reporting System. Click here for more information.

January 7, 2011

Recall Notice: Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

On January 7, 2011, The Triad Group issued a recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. The recall pertains to all such products marked as either STERILE or non-sterile. The recall was initiated over concerns of possible product contamination with Bacillus cereus. Continued use of affected product could put at-risk patients at risk of developing life-threatening infections.

Recalled lots were distributed nationwide to retail pharmacies and sold in individual packets and in boxes containing 100 packets. The affected alcohol prep pads, alcohol swabs, and alcohol swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin. If a consumer has any of these types of products in their possession listing "Triad Group" as the manufacturer, they should not use the product and should return it to the place of purchase for a full refund. Click here for more information.

January 5, 2011

Recall Notice: AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I Recall

On January 5, 2011, AngioScore Inc. issued a recall of certain AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platforms manufactured by the company. The recall affects 17,682 units distributed from 09/2007 to 11/2010, including the following model part (REF) numbers and includes all sizes and lot codes for each model listed: 2076-4020, 2076-5020, 2076-6020, 2092-6020, 2105-6020. The devices are being recalled due to a design defect which can cause unintended fracture and peeling, resulting in fraying of the bond and/or detachment of the distal end of the scoring element. AngioScore Inc. is advising customer to immediately discontinue use of any recalled product. Not doing so may lead to retained device fragments or arterial injury that could lead to the need for surgical intervention or death Click here for more information.

December 23, 2010

Recall Notice: American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50mL Single Dose Vials Due to Particulate Matter

On December 23, 2010, American Regent issued a voluntary recall of its Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50 mL Single Dose Vials due to the possibility of vials containing particulate matter. If use is not discontinued, potential adverse health events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. For this reason, American Regent is undertaking this recall in consideration of the potential for safety issues if any unapproved product is administered to patients. To identify recalled product lot numbers, expiration dates, and additional instruction please, reference the Recall Notice in the following link. Click here for more information.

December 22, 2010

Recall Notice: Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results (including Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ, ReliOn Ultima)

On December 22, 2010, The FDA and Abbott Diabetes Care issued a recall notification to healthcare professionals and patients regarding the recall of 359 different lots of glucose test strips marketed under the following brand names: Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima. The issue relates to the insufficient absorption of blood into the test strip. Test strips included in the recall may give falsely low blood glucose results, which can lead patients to try to raise their blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading. The recalled test strips are used with Abbott's Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ and ReliOn Ultima blood glucose monitoring systems. As many as 359 million strips may be affected by the recall. The test strips, which were manufactured between January and May 2010, are sold both in retail and online settings directly to consumers, but are also used in health care facilities. Patients with diabetes should be aware of this problem and take steps to prevent it from affecting their health. Customers can check if they have tests trips from the recalled lots by visiting Abbott's website to look up their product lot number: http://www.precisionoptiuminfo.com. Click here for more information.

December 1, 2010

Recall Notice: B. Braun addEASE Binary Connector: Class I Recall -Stopper Fragments May Enter Bag

On November 30, 2010, B Braun Medical Inc. issued a reiteration of a prior June 28, 2010 recall on use of its addEASE Binary Connectors. The organization identified that when an addEASE Binary Connector is inserted into a partial additive bag (PAB) stopper, fragments of the stopper may enter the bag, resulting in a small amount of visible particles in the solution. These particles can potentially enter a patient's body and lead to serious injury and/or death. It is recommended that anyone currently using this product discontinue doing so immediately. Click here for more information.

November 15, 2010

Recall Notice: Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

On November 15, 2010, the FDA and Sigma International Gerneral Medical Apparatus, LLC reiterated an earlier recall notice from September 15, 2010 regarding Sigma Spectrum Infusion Pump Model 35700. The recall includes pumps that have serial numbers from 706497 to 724065. The recall was issued because these units may fail suddenly, causing inaccurate flow conditons during use, ranging from back flow to over-infusion, including free flow. Also, of concern in that the pump does not issue and alarm when this occurs which could result in the serious injury of death of the user.

Should you be in possession of a recalled pump, Sigma is requiring the return of the devices. For questions and return information please, contact the company at 1-866-482-2893, Monday through Friday, 8 AM though 5 PM (Eastern Time). Click here for more information.

November 11, 2010

Recall Notice: Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem

On October 8, 2010, WalkMed Infusion LLC. and the FDA notified healthcare professionals of a nationwide recall of the Triton Pole Mount Infusion Pump, serial numbers 001 through 500 and serial numbers TR1401 through TR 2559, manufactured and sold before June 2010. The issue stems from a problem with the latch alarm on the pump door which if gone unnoticed could potentially lead to an over infusion of medication to the patient. It is requested that consumers who have Triton Pole Mount Infusion Pumps which are being recalled should return the pump to the manufacturer. Click here for more information.

October 29, 2010

Recall Notice: Heparin Sodium (B. Braun): Recall - Trace Contaminant

On October 29, 2010, B. Braun Medical Inc. and FDA notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because testing indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010. Should you be in possession of this product discontinue use immediately. To identify Product lot numbers, expiration dates, and recall instructions please, reference the Recall Notice in the following link Click here for more information.

October 18, 2010

Recall Notice: CareFusion Corp. Issues Recall of Alaris PC Units (Model 8015) Due to Potential For Delay or Interruption of Therapy

On October 15, 2010, CareFusion Corporation issued a recall of its Alaris PC Units (Model 8015) manufactured between the time period of December 20, 2008 through September 8, 2009 and distributed from December 20, 2008 through June 28, 2010. The organization identified that under certain wireless network conditions, a communication error can occur which can lead to the freezing/interruption of the PC Unit screen and a subsequent delay in therapy. Should the communication error occur during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down resulting in a delay or interruption in therapy which could lead to serious injury or death. Any users experiencing this problem should remove the device from service and contact the CareFusion Recall Center immediately at 888.562.6018 or via email at SupportCenter@carefusion.com. Corrective action will require a hardware update to all affected units. Please also note that CareFusion does not require that the devices be returned. Click here for more information.

October 18, 2010

Recall Notice: Excelsior Medical Identifies Potential Loss of Sterility and Leaking in 5ml Fill in 6cc Prefilled Saline Flush Syringes

On October 15, 2010, Excelsior Medical issued a recall notice that several models of its Prefilled Saline Flush Syringes had the potential to leak and/or lose sterility. The recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Please note that using syringes that have a sterility issue could result in systemic infection, which may lead to serious injury and/or death. Should you be in possession of any of these syringes, please discontinue use immediately and return them to your point of purchase. It is advised that healthcare professionals and patients report any adverse health events related to use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting System. Click here for more information.

September 27, 2010

Amgen Initiates Voluntary Nationwide Recall of Certain Lots of EPOGEN ® and PROCRIT ®

Amgen announced September 24, 2010 that certain lots of EPOGEN(R) and PROCRIT(R) (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution. The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product. The recall is being conducted in cooperation with the United States Food and Drug Administration. Evaluations by Amgen and Centocor Ortho Biotech Products, L.P. found a low potential to impact patients who may have received the affected product. The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular events (e.g., phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity. Adverse events related to EPOGEN should be reported to 1-800-77-AMGEN. Adverse events related to PROCRIT should be reported to 1-800-547-6446. Consumers with questions regarding this recall can contact Amgen at 1-800-77-AMGEN (open 24 hours per day, 7 days per week) or Centocor Ortho Biotech Products at 1-800-547-6446 (open 24 hours per day, 7 days per week). Click here for more information.

September 17, 2010

Valcyte (valganciclovir hydrochloride) Label Change: Possible overdose in pediatric patients

The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals of new pediatric dosing recommendations for Valcyte (valganciclovir hydrochloride) oral tablets and oral solution. This change is being made to prevent potential valganciclovir overdosing in children with low body weight, low body surface area, and below normal serum creatinine. The revised dosing recommendations are being updated to include an upper limit on the calculated creatinine clearance using the modified Schwartz formula, which is used to calculate the pediatric dose of Valcyte. Valganciclovir is an antiviral medication that can be effective for the prevention of cytomegalovirus (CMV) disease in children 4 months to 16 years of age who have undergone a kidney or heart transplant. Cytomegalovirus is a member of a group of herpes-type viruses that can cause disease in different parts of the body. Patients with weakened immune systems, such as organ transplant patients, are particularly susceptible to CMV infection and must take medications such as Valcyte to prevent the disease. Click here for more information.

September 15, 2010

BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall

Westmed, Inc. is initiating a nationwide recall of 24,384 units of BagEasy Manual Resuscitation Devices. Select lots of the BagEasy device have been found to have a potential for disconnection at the retention ring of the patient port manifold. Disconnection causes the unit to be inoperable, which potentially could result in treatment delays while another unit is obtained or technician switches to a different method of resuscitation. This recall is classified by the FDA as a Class I Recall. Consumers who have units from the identified lots of BagEasy manual resuscitation devices which are being recalled should stop using them and return the product to Westmed or their distributor. To obtain the full listing of part numbers and lot numbers, visit the FDA website (www.fda.gov) or contact 1-800-975-7987. Westmed voluntarily recalled these products after learning of units disconnecting at user facilities. The FDA has been apprised of this action. Westmed has become aware of a potential for disconnection at the patient port retention ring assembly of the BagEasy manual resuscitation device after receiving reports from three separate facilities regarding units disconnecting during setup or use. The healthcare providers obtained another unit and continued with setup or treatment. The BagEasy manual resuscitation device was distributed to other medical device distribution companies as well as directly to hospitals and other treatment facilities. It can be identified by product labeling that contains part and lot numbers. Westmed is notifying its distributors and customers by certified mail and direct contact by sales representatives and is arranging for return of all recalled products. Click here for more information.

September 10, 2010

Fresenius Urgent Recall for AC Power Cords

Fresenius Medical Care is initiating this recall for certain Fresenius devices that may have a defective plug, which is part of an AC power cord manufactured by Electri-Cord Manufacturing Company. This alert is being issued in response to a FDA alert regarding customer reports of sparking, charring and fires of similarly designed AC power cores in non-dialysis products manufactured by other companies. Fresenius is advising all customers to assess whether their devices have the affected Electri-Cord AC power cords and inspect the cord plugs for evidence of damage (charring, discoloration of the plastic, broken or loose prongs). The potential risks from power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires, which may be exacerbated in an oxygen rich environment. Depending on the device, therapy, and environment, these failures may lead to potential serious injury or death. Fresenius Medical Care NA has not received any reports of serious patient harm related to the situation. Click here for more information.

August 16, 2010

FDA Proposes Withdrawal of Low Blood Pressure Drug: Companies failed to provide evidence of clinical benefit of midodrine hydrochloride

The U.S. Food and Drug Administration today proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done. Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options. The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies. To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities. Orthostatic hypotension is a condition in which patients are unable to maintain blood pressure in the upright position and, therefore, become dizzy or faint when they stand up. Generic versions of the drug are made by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories. According to a database used by the FDA, about 100,000 patients in the United States filled prescriptions for brand or generic forms of midodrine in 2009. Access the FDA information at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222580.htm

March 19, 2010

FDA Drug Safety Communication: Ongoing safety review of high-dose Zocor* (simvastatin) and increased risk of muscle injury

The U.S. Food and Drug Administration (FDA) is informing the public about an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class. The muscle injury, also called myopathy, is a known side effect with all statin medications. Patients with myopathy generally have muscle pain, tenderness or weakness, and an elevation of a muscle enzyme in the blood (creatine kinase). The higher the dose of statin used, the greater the risk of developing myopathy. The risk of myopathy is also increased when simvastatin, especially at the higher doses, is used with certain drug. The most serious form of myopathy is called rhabdomyolysis. It occurs when a protein (myoglobin) is released as muscle fibers break down. Myoglobin can damage the kidneys. Patients with rhabdomyolysis may have dark or red urine and fatigue, in addition to their muscle symptoms. Damage to the kidneys from rhabdomyolysis can be so severe that patients may develop kidney failure, which can be fatal. Known risk factors for developing rhabdomyolysis include age (> 65 years), low thyroid hormone levels (hypothyroidism), and poor kidney function. Myopathy and rhabdomyolysis are listed as possible side effects in the simvastatin and other statin drug labels. For more information, visit the FDA website by clicking here.

March 2, 2010

Baxter HomeChoice Peritoneal Dialysis Cycler

Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter’s recent Urgent Product Recall regarding Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall. This action has been classified as a Class I recall because of the risk of serious injury or patient death that could be associated with the use of this device. Over the last two years, Baxter has received serious injury reports and at least one patient death report associated with this issue. For more information, visit the DA website by clicking here.

February 26, 2010

OneTouch SureStep Test Strips (LifeScan): Recall

LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL. If patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death. The eight lots of consumer OneTouch SureStep Test Strips being recalled are identified in the firm's press release. Lot numbers are located on the outer carton and test strip vial. LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010. It is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher. Read the complete MedWatch 2010 Safety summary, including a link to the firm's press release.

February 16, 2010

Drug Safety Communication : Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp

FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a REMS risk management program. As part of the risk management program, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving an ESA. Under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program. FDA is requiring a REMS because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions. Click here for more information including critical patient education on this topic.

January 28, 2010

RECALL: Edwards Lifesciences Aquarius Hemodialysis System

FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death. The recall includes model numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The product was distributed from July 12, 2007 through March 18, 2009. Baxter International, Inc. is the U.S. distributor of the Aquarius. The company notified its customers of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period. The company received reports of clinically significant fluid imbalance. When a certain level of fluid imbalance is detected the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy. By repeatedly overriding the balance alarm without solving the issue, such as a closed clamp or kinked line, it is possible to remove too much fluid from or replace too much fluid to the patient. In extreme cases, this could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death. Public Contact: Baxter International, Inc. is the U.S. distributor of the Aquarius. For questions regarding the Aquarius, contact the Baxter Clinical Help Line at 1-888-736-2543. Click here for more information.

January 21, 2010

Nipro Medical Corporation Issues a Voluntary Recall of All GlucoPro Insulin Syringes

Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump). These syringes may have needles that detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection. Consumers who have GlucoPro Insulin Syringes should stop using and return them to point of sale for reimbursement. This recall includes all product codes and lot numbers with expiration dates before 2011-11 (Nov 1, 2011). The firm voluntarily recalled the products after learning of the possibility of needle detachment. FDA has been apprised of this action. No injuries have been reported to date. Product was distributed nationwide, including Puerto Rico. Company is notifying its distributors and customers by Fax and Email and is arranging for return of all recalled products. Consumers with questions may contact the company at 305.599.7174 x249. Click here for more information.

October 27, 2009

Accusure Insulin Syringes Qualitest Pharmaceuticals - Recall

Qualitest Pharmaceuticals and FDA notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe. Click here for more information.

October 19, 2009

Dexferrum (iron dextran injection) - Labeling Change

American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum. Fatal reactions have followed the test dose of iron dextran injection, even in situations where the test dose was tolerated. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions. It is recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration. For more information, visit FDA Medwatch and American Regent.

October 12, 2009

Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators

Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR). The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: http://www.unomedical.com/?pageid=H3160. Unomedical is contacting customers to arrange for the return and credit of all MPR units subject to this recall by sending notification letters to distributors and customers. Customers with questions are urged to contact Unomedical at 1-800-634-6003.

October 3, 2009

Philips Issues Worldwide Recall of Select Heartstart Fr2+ Automated External Defibrillators

Philips announced today that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured between May, 2007 and January, 2008 are included in the voluntary recall. For more information, visit http://www.fda.gov/Safety/Recalls/ucm185108.htm

October 1, 2009

New USP Standards for Heparin Products Will Result in Decreased Potency Adjustments may be needed to achieve desired anticoagulant effect in some patients

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

September 16, 2009

LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)

Audience: Emergency medical personnel, consumers.

FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy. Click here to find the serial numbers associated with this recall. An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death. Click here for more information about this recall.

September 3, 2009

Myfortic (mycophenolic acid)

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals.

Novartis and FDA notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and ADVERSE REACTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety information. PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of Myfortic therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk. Read the complete MedWatch Safety summmary (corrected) by clicking here.

August 26, 2009

Levemir Insulin (Novo Nordisk):Stolen vials still may be on market

FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots. Read the complete MedWatch 2009 Safety summary including a link to the FDA News release and the original June 13,2009 alerts here.

August 24, 2009

Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]

Audience: Patients with diabetes mellitus, pharmacists and diabetes healthcare professionals.

Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin Syringes. The syringes in these lots have been found to have needles which can detach from the syringe. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection. Consumers who have any recalled Accusure Insulin Syringes (31 G –Short Needle-either 1/2 cc or 1 cc, lot number 6JCB1 or lot number 7CPT1) should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. The lot number can be found on the white paper backing of each individual syringe. These recalled products were distributed from January 2007 through June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico). This information is posted here.

August 13, 2009

GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology

Audience: Diabetes healthcare professionals, hospital risk managers, patients.

FDA notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.

GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product. The FDA Public Health Notification provides a list of GDH-PQQ Glucose Test Strips and recommends that healthcare practitioners avoid using GDH-PQQ glucose test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances.

May 6, 2009

CDC: Hepatitis B Vaccine

In December 2008, Merck communicated with CDC that it expected to deplete available adult and dialysis formulations of their hepatitis B vaccine, Recombivax HB® in the first quarter of 2009. Once depleted, these formulations will be unavailable for the remainder of 2009. Supply of GSK's Adult hepatitis B vaccine (Adult Engerix-B®) and Adult hepatitis A/hepatitis B combination vaccine (Twinrix®) is sufficient to meet demand for routine adult usage of this vaccine as well as CDC's ongoing High Risk Adult Hepatitis B Initiative. This information is posted at http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm

May 6, 2009

Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump

Audience: Diabetes healthcare professionals, patients.

Disetronic Medical Systems Inc. and FDA notified healthcare professionals about a defect in the “up” and/or “down” buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the “up” and/or “down” buttons. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. Users may contact ACCU-CHEK Spirit hotline noted in the Press Release for a replacement pump or for any other questions regarding this potential defect.

Read the complete MedWatch 2009 Safety summary, including a link to the firm's press release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Spirit

April 9, 2009

ZOLL AED Plus Defibrillator

ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. On February 12 and March 31, 2009, the company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device. Please visit http://www.fda.gov/cdrh/recalls/recall-021209b.html and http://www.zollaedplusbatteryhelp.com/

April 1, 2009

Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)

Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase. Please visit http://www.fda.gov/oc/po/firmrecalls/caraco03_09.html

March 11, 2009

Baxter recalls Colleague Single and Triple Channel Volumetric Infusion Pumps

FDA notified healthcare professionals of a Class 1 Recall of model numbers Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163. These products were manufactured and distributed from February, 1997 through December, 2008. The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps.

Read the FDA notice at http://www.fda.gov/cdrh/recalls/recall-012309.html and also read Baxter's press release here.

February 12, 2009

CellCept (mycophenolate mofetil)

FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis.

Read the complete MedWatch 2009 Safety summary including links to the Dear Healthcare Professional and Dear Pharmacist letters, the new Medication Guide and the current Prescribing Information, at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#CellCept

December 2, 2008

Innohep (tinzaparin sodium injection)

FDA has received information about the clinical study: Innohep in Renal Insufficiency Study (IRIS) that was stopped in February, 2008 by the study’s Data Safety Monitoring Committee because of an interim finding of an increase in all-cause mortality in patients who received Innohep. Information on the patients enrolled in the study, on the heparin used to manufacture Innohep, and on the heparin used in the study is still being collected and analyzed.

In July 2008, the company revised the prescribing information to restrict the use of Innohep in patients 90 years of age or older. FDA is concerned that the preliminary data from the IRIS study suggest that the increased risk of mortality is not limited only to patients 90 years of age or older. Therefore, FDA has requested that the company revise the labeling for Innohep to better describe the overall study results which suggest that, when compared to unfractionated heparin, Innohep increases the risk of death for elderly patients (i.e., 70 years of age and older) with renal insufficiency. Healthcare professionals should consider the use of alternative treatments to Innohep when treating elderly patients over 70 years of age with renal insufficiency and DVT, PE, or both. This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA anticipates submission of the final IRIS study report in January, 2009 and plans to complete its review soon thereafter. FDA will communicate its conclusions and any resulting recommendations to the public at that time. FDA will consider additional regulatory actions as appropriate after thorough review of all applicable data from the manufacturer of Innohep.

Read the complete MedWatch 2008 Safety summary, including a link to the FDA Communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep

November 6, 2008

ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)

Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam's Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html

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Alerts & Recall Notifications

March 18, 2013

Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water,50ml For Injection Due To Mold Contamination

March 18, 2013

Vascular Solutions Zerusa Ltd. Issues Recall of Guardian� II and Guardian� II NC Hemostasis Valves

February 27, 2013

Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication- FDA Suspends Pediatric Clinical Trials After Report Of Death

February 25, 2013

OMONTYS®: Drug Recall Communication - Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS� (peginesatide) Injection.

December 27, 2012

Heparin: Drug Safety Communication - Important change to heparin container labels to clearly state the total drug strength

November 20, 2012

HeartSine Samaritan Public Access Defibrillator 300/300P: Class I Recall - Device May Intermittently Turn On and Off

November 9, 2012

Baxter Healthcare Corp. Buretrol Solution Sets: Class 1 Recall - May Not Function as Expected

November 2, 2012

FDA Safety Announcement: Ameridose, LLC: Recall of Unexpired Products in Circulation

October 29, 2012

FDA Safety Announcement: Hospira Symbiq Infusion System Touchscreen: Class 1 Recall - May Not Respond to Selection 16026 Symbiq One Channel Infuser 16027 Symbiq Two Channel Infuser

October 19, 2012

FDA Safety Announcement: FDA Statement on Fungal Meningitis Outbreak: Additional Patient Notification Advised

October 19, 2012

FDA Safety Announcement: Ventlab Corporation Issues Nationwide Recall of its Manual Resuscitators

October 17, 2012

FDA Safety Announcement: FDA MedWatch: Safety Information and Adverse Events Reporting

October 16, 2012

FDA Safety Announcement: Fungal Meningitis Outbreak - Additional Patient Notification Advised

October 11, 2012

FDA Safety Announcement: Asahi Kasei, REXEEDTM - 15 SX, Hemodialyzer - Recall Class 2

October 10, 2012

FDA Safety Announcement: Asahi Kasei, REXEEDTM - 18 LX, Hemodialyzer - Recall Class 2

August 23, 2012

FDA Safety Announcement: CareFusion 303, Alaris Pump Module, Model 8100: Class I Recall - Potential for Pump Malfunction to Stop Infusion

August 3, 2012

FDA Safety Announcement: Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I Recall - System Errors May Cause Device Shutdown

August 1, 2012

FDA Safety Announcement: B. Braun Infusomat Space Infusion System: Class I Recall - Potential for Breakage of Anti Free Flow Clip Catch

August 1, 2012

FDA Safety Announcement: CareFusion Alaris PC Unit, Model 8015: Class I Recall - Error Code

June 27, 2012

FDA Safety Announcement: Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate - Recall Class 1

June 26, 2012

FDA Alert: Cefepime: Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment

June 22, 2012

FDA Alert: Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

June 15, 2012

FDA Alert: Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall - Risk of Fire, Loss of Supplemental Oxygen

May 25, 2012

FDA Alert: Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors

August 27, 2011

Recall Notice: H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel Recall - Inadequate Microbial Testing

August 3, 2011

Recall Notice: Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: Class I Recall

July 7, 2011

FDA Notice: Nulojix (belatacept) ? Risk Evaluation and Mitigation Strategy (REMS)

June 24, 2011

Recall Notice: Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendation

May 10, 2011

Recall Notice: Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall - Software Defect May Cancel Shock

May 6, 2011

Recall Notice: Weck Hem-o-Lok Ligating Clips: Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy

May 3, 2011

Recall Notice: Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency

March 29, 2011

Recall Notice: Roche ACCU-CHEK FlexLink Plus Infusion Set: Class I Recall - Potential for Under-Delivery of Insulin

March 29, 2011

Recall Notice: Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A, D

March 18, 2011

Recall Notice: American Regent Injectable Products: Recall - Visible Particulates in Products

March 18, 2011

Recall Notice: H & P Industries Povidine Iodine Prep Pads: Recall - Potential Microbial Contamination Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources

February 1, 2011

Recall Notice: B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall - Hardware May Become Unresponsive

January 20, 2011

Recall Notice: Fresenius Medical Care - CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for use with the Blood Volume Monitor

January 7, 2011

Recall Notice: Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

Baxter Healthcare Corp. Buretrol Solution Sets:
Class 1 Recall - May Not Function as Expected

FDA Safety Announcement: Hospira Symbiq Infusion System Touchscreen: Class 1 Recall - May Not Respond to Selection
16026 Symbiq One Channel Infuser
16027 Symbiq Two Channel Infuser

FDA Safety Announcement: Asahi Kasei, REXEED^TM - 15 SX, Hemodialyzer - Recall Class 2

FDA Safety Announcement: Asahi Kasei, REXEED^TM - 18 LX, Hemodialyzer - Recall Class 2