Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Risk of Device "Lockup" (Freezing)Friday, March 1, 2019
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. LIFEPAK15 Monitor/Defibrillator (LP15)
- Model: LIFEPAK 15 Monitor/Defibrillators with Printed Circuit Board Assembly (PCBA) part no. 3206834-011 or 3206834-012
- Serial/Lot Numbers: See "Full List of Affected Devices"
- Manufacturing Dates: March 21, 2013, to July 18, 2016
- Distribution Dates: March 21, 2013, to July 18, 2016
- Devices Recalled in the U.S.: 8,164
Physio-Control's LIFEPAK 15 Monitor/Defibrillator is used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are connected to the defibrillator to help the device analyze a patient's heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed. The LIFEPAK 15 monitor displays the patient's heart rhythm so the health care provider can study the heart's electrical activity.
The LIFEPAK 15 is designed to be used only by trained medical personnel during ground transport of a patient.
Reason for Recall
Physio-Control is recalling its LIFEPAK 15 Monitor/Defibrillator because the device may "lockup" (freeze) after a shock is delivered. When this occurs, the device's monitor display goes blank and there is no response from the keypad or the device although the device's LED lights remain on and indicates the device still has power.
Once the LIFEPAK 15 freezes, it cannot provide defibrillation therapy until the device is reset by restarting the device or removing and reinserting all connected power sources. The resulting delay in delivering a shock could and has resulted in serious patient injury including death.Read More
Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/HydrochlorothiazideFriday, March 1, 2019
Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.
Risk Statement: The impurity detected is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. Macleods is recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg that contains NDEA above the interim acceptable daily intake levels released by the FDA.
To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall.
Losartan Potassium/Hydrochlorothiazide combination tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium/Hydrochlorothiazide combination tablets, USP should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
The product subject to recall is listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.Read More
Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test StripsThursday, December 27, 2018
This announcement clarifies information included in Terrific Care, LLC's press release issued on 12/19/2018
On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. This recall only includes CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc via its website/phone calls/facsimal of All Catalog/REF Numbers that DO NOT END IN 160.
The products distributed by Terrific Care, LLC / Medex Supply Dist, Inc. have been found to inaccurately report high INR test results. Patients taking warfarin who receive inaccurate INR results above their target therapeutic range may be at risk for inappropriate therapeutic measures such as a warfarin dose reduction, interruption of warfarin use, or administration of vitamin K.Read More
Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain PatientsThursday, December 27, 2018
FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death. They can occur with fluoroquinolones for systemic use given by mouth or through an injection.Read More
Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USPThursday, December 27, 2018
Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.Read More
Mylan Expands Its Voluntary Nationwide RecallMonday, December 10, 2018
Mylan N.V. (NASDAQ: MYL) today (12/4/2018) announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths).
Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).Read More
Teva Pharmaceuticals USA Issues Voluntary Nationwide RecallFriday, November 30, 2018
Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.
Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets are used for the treatment of high blood pressure.Read More
Outbreak Alert Update: Potential Life-Threatening Vitamin K-Dependent Antagonist Coagulopathy Associated With Synthetic Cannabinoids UseTuesday, November 27, 2018
This COCA Clinical Action updates the message sent on April 5, 2018: https://content.govdelivery.com/accounts/USCDC/bulletins/1e6dac3
Since the index case was identified on March 8, 2018 in Illinois, at least 160 people have presented to Healthcare facilities with serious unexplained bleeding. The preponderant number of patient presentations were in Illinois with other cases being reported from Florida, Indiana, Kentucky, Maryland, Missouri, Pennsylvania, Virginia, and Wisconsin. Laboratory investigation confirms brodifacoum exposure in at least 60 patients. There are at least 3 fatalities. At least 7 synthetic cannabinoids product samples related to this outbreak have tested positive for brodifacoum. At least one synthetic cannabinoids product has tested positive for both synthetic cannabinoid AB-FUBINACA and brodifacoum.Read More
Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9%Tuesday, November 27, 2018
Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain natural rubber latex.Read More
Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and HydrochlorothiazideFriday, November 9, 2018
Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).Read More