America’s Unsafe Medical Products

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Circulatory Support Motor May Slow Down or Stop
> Issue date: November 6, 2019
> Type of Alert: Recall

Abbott is recalling 381 CentriMag Acute Circulatory Support Systems that may slow down or stop, putting the patient at risk of service adverse health consequences such as stroke, severe organ damage or death. The FDA has identified this as a Class I recall.

Potentially Nonsterile Topical Anesthesia Recalled
> Issue date: November 1, 2019
> Type of alert: Recall

Fagron is voluntarily recalling all unexpired lots of its Lets Gel Kit convenience packs due to contaminants found in some samples.

Particulate Matter in Hospital Injections
> Issue date: October 30, 2019
> Type of alert: Recall

ICU Medical is voluntarily recalling one lot of its lactated Ringer’s injection and one lot of 0.9% sodium chloride injection due to the presence of particulate matter. The injections are used for parenteral replacement of extracellular losses of fluid and electrolytes.

Stapling Device May Release Malformed Staples
> Issue date: October 30, 2019
> Type of alert: Recall

Ethicon is recalling four models of its Echelon Flex 60 stapler/articulating endoscopic linear cutter due to a flaw that may result in malformed staples. This is a Class 1 recall of 8,256 devices distributed in the United States between August 1 and September 26, 2019. To date, Ethicon has received reports of seven serious injuries and one death related to the faulty devices.

Risk of Leaks From Endovascular Grafts
> Issue date: October 28, 2019
> Type of alert: Safety communication

The FDA continues to evaluate new information related to blood leaking into an aneurysm following an Endologix AFS endovascular graft using certain materials. The agency recommends lifelong treatment for patients treated with any endovascular graft and is “emphasizing the importance of at least yearly, lifelong follow-up” for patients with Endologix AFX grafts.

Possible Contamination in Anxiety Disorder Drug
> Issue date: October 26, 2019
> Type of alert: Recall

Mylan Pharmaceuticals is recalling one lot of Alprazolam tablets due to potential contamination. The drug is used to manage anxiety disorder, the short-term relief of symptoms of anxiety and the treatment of panic disorder, with or without agoraphobia.

Ranitidine Antacid Medication Recalled
> Issue date: October 25, 2019
> Type of alert: Recall

Lannett is voluntarily recalling all of its ranitidine syrup. The products may be contaminated with a carcinogen known as NDMA.