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The medical device maker started the recall process on Dec. 27 last year and has recalled 66,390 devices in the United States. The recalled devices were distributed for two years until Oct. 10, 2023.
There have been 51 complaints, one death related to this recall and one reported injury, the FDA said. The company has asked customers to not use the device for high-risk medications, and only use ...
The medical equipment maker recalled certain models of its AirLife Manual Resuscitators, a single patient-use device intended for respiratory support, due to a manufacturing defect. The use of the ...
The devices are used in patients undergoing cardiac and non-cardiac surgery, and to treat those who have had heart failure or have acute coronary syndrome, a group of diseases in which blood flow ...
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 ...
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 ...
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.
The FDA said ResMed was recalling these masks to update the labels and add more warnings and information. The California-based medical device maker started the recall process on Nov. 20 and has ...