Sotrovimab for the Treatment of COVID-19
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Dewei Medical Equipment is recalling DNA/RNA Preservation Kits because they were distributed to U.S. customers without FDA authorization, clearance, or approval.
New labeling for AFX2 Endovascular AAA System (AFX2) includes information to better inform patients and health care providers of the risk of Type III endoleaks
La nueva etiqueta del sistema endovascular AFX2 para AAA (AFX2) incluye información para informar mejor a los pacientes y a los profesionales de la salud sobre el riesgo de endofugas de tipo III.
The FDA is issuing this update to inform the health care community of the final PAS results and updated labeling for the Impella RP System by Abiomed.
The FDA is alerting health care facilities and providers of a shortage of Getinge Maquet/Datascope Intra-Aortic Balloon Pump (IABP) devices, including limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABP parts.
Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are now being recalled to the c
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