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The FDA has announced over 20 recalls across the U.S., including food items, cosmetics, drugs, dietary supplements, and medical devices.
The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM) is the medical regulatory body in Germany. It operates under the Federal Ministry of Health (BMG). It is headquartered in Bonn, Germany. [1] Its president is Karl Broich. [2]
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
A GAO follow-up study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious shortcomings still existed. Under the Safe Medical Devices Act of 1990 (SMDA), device user facilities must report device-related deaths to the FDA and the manufacturer, if known. The facilities must also report ...
B axter International Inc. issued an urgent medical device recall for Life2000 ventilators that have an attached battery charger dongle on Wednesday, after the company received a report of a ...
About 10,655 devices, which were distributed between Oct. 26, 2022 and July 17, 2023, have been recalled by the company. B. Braun Medical did not immediately respond to a Reuters request for comment.
2017: medical cannabis in California found to contain dangerous bacteria and fungi, causing at least one fatality. [ 19 ] 2012 – 2018: From 2012 to 2018 massive amounts of generic versions of an entire class of angiotensin II inhibitor blood pressure medications (collectively called "sartans") were made with contaminated ingredients.
(Reuters) -The U.S. Food and Drug Administration (FDA) on Wednesday classified the recall of Philips' medical imaging devices as most serious as their use could cause serious injuries or death.