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Alerts and Recalls

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  • Liberty Select Cycler Recall

    Tuesday, May 1, 2018

    On 01/25/2018, Fresenius Medical Care Renal Therapies Group, LLC sent Urgent Medical Device Correction letters to affected Home Therapy Nurse Managers (HTNs). On 01/31/2018, the firm sent letters to affected patients. The letters informed customers of the recall and stated that patients who are considered "slow drainers" and experience M65 Scale warnings during one or more drain cycles are at increased risk.

    On 03/29/2018, the firm sent out a second Urgent Medical Correction Letter to HTNs, followed by a patient communication sent on 04/02/2018. In the second communication, the firm amended that slow drainers can develop Overfill/IIPV even without receiving M65 scale warning.

    Health care providers and patients using the device were advised to monitor drain rates and address the reasons for slow draining, such as constipation, fibrin deposition, peritonitis, and catheter malposition. Health care providers were advised to continue to review risk factors and symptoms of Overfill/IIPV with PD nursing staff and patients with extended drain times.

    The firm is not requesting the return of the recalled device at this time. For additional information and alternative treatment options, please contact the FMCRTG Medical Information Line at 1-855-616-2309. Hours of operation are 8:30AM-5:00PM (EST), Monday - Friday. Online requests may be submitted at any time at www.fmcna-medinfo.com.

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  • Prismaflex Control Unit. Dialyzer Recall

    Thursday, April 19, 2018

    Baxter Healthcare Corporation is recalling the Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. Baxter has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally.

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  • Class 2 Device Recall 2008 Series Hemodialysis Machine

    Friday, April 13, 2018

    Fresenius Medical Care Renal Therapies is recalling its dialyzer, high permeability with or without sealed dialysate system, 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.

    When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained Low Efficiency Dialysis) program the display will show an invalid message and the UF pump will run at the recirculation UF rate which may be up to 4000ml/hour. The SLED program is required to limit the UF rate to a maximum of 1000 ml/hour.

     

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  • BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall

    Tuesday, March 27, 2018

    BD is recalling their Vacutainer EDTA Blood Collection Tubes with lavender, tan, pink and green rubber tube stoppers due to a chemical in the rubber tube stopper that interferes with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology. ASV is the methodology used in Magellan Diagnostics’ LeadCare Testing Systems. The tube stoppers contain a substance called thiuram that can sometimes release sulfur-containing gases, which may dissolve into the blood sample and bind the lead particles. This chemical reaction makes it difficult for the Magellan lead tests to detect the correct amount of lead in the sample and may cause falsely lower test results. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning. The use of affected product may cause serious adverse health consequences.

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  • Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall

    Wednesday, March 7, 2018

    Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of ten lots of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g. A detailed listing of products and lots is listed in the recall notice. These products were manufactured by Gland Pharma Ltd. and distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Methylprednisolone Sodium Succinate for Injection, USP to the user level due to the discovery of high out of specification impurity results detected during routine quality testing of stability samples for two lots.

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  • Acyclovir 400mg Tablets by Apace Packaging: Recall

    Wednesday, February 21, 2018
    Apace Packaging LLC is voluntarily recalling one lot of Acyclovir Tablet, USP, 400mg, 50ct Unit Dose, NDC# 50268-061-15, Lot Number 19900, to the retail level. These products have been recalled due to a product mix-up. A small number of blister cards containing Acyclovir Tablets, 400mg, UD Blister...

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  • Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall

    Friday, January 12, 2018
    International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel Tablets USP, 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP...

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  • inezolid Injection by Auromedics Pharma: Voluntary Recall

    Thursday, December 28, 2017
    AuroMedics Pharma is voluntarily recalling one lot of Linezolid Injection 600mg/300mL flexible bags, NDC 55150 -242 -51 batch CLZ160007 expiration August 2018 to the hospital level. This batch was distributed May 15 through August 14, 2017. The product was found to contain white particulate matter...

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  • Physio-Control Inc. Recalls Defibrillation Electrodes Due to Incorrect Placement Instructions for Infants Depicted on Artwork

    Wednesday, December 20, 2017
    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.Physio-Control Inc. is recalling infant/child defibrillation electrodes because the artwork on the pads within the packaging shows incorrect placement...

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  • Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings

    Wednesday, December 20, 2017
    FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has...

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