JIANGSU JUMAO X-CARE Medical Equipment Co. issued a recall for the JMC5A Ni/Tru-Aire-5 Oxygen Concentrator after incidents of spontaneous fires. These fires could cause burns or worse. Patients are ...
Product recalls are a major headache for pharma ... with extensive experience in medical device, biotechnology and pharmaceutical marketing. A graduate of the University of Texas, Amy joined ...
The FDA labeled a recall of integrated arterial catheters made by Medline Class I, the most serious kind of recall.
When it comes to medical devices, recalls can include not only "removals ... a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they ...
These strategies can create a healthcare ecosystem that prioritizes patient safety, empowers consumers with information and ...
A recent study identified 157 cardiovascular devices recalled from 2013 to 2022. Recalls were commonly attributed to device ...
Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians ...
sent all affected customers an urgent medical device correction and information about which patients may need their data reprocessed. This is a Class I recall, the FDA's most serious ...
The FDA has recalled Mercury Medical’s Neo-Tee T-Piece Resuscitator, a gas powered resuscitator intended primarily for ...
Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical ...
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