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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]
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.
The recall applies to Life2000 ventilators with the product code MS01-0118 that have the attached battery charger dongle, and were distributed in the U.S. from Aug. 21, 2023 to April 2, 2024 ...
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, and infant formulas). As of the summer of 2011 ...
(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.
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
(Reuters) - The U.S. Food and Drug Administration classified a recall of Teleflex's inflatable devices that increase blood supply to the heart muscle as "most serious".