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The Food and Drug Administration has announced on its website that medical device maker St. Jude Medical last month recalled a device used in heart surgery because of the risk that it could cause ...
St. Jude Medical was founded in 1976 to further develop bi-leaflet artificial heart valves, which were originally created in 1972 at the University of Minnesota. [4] [5] St. Jude Medical's bi-leaflet valve was developed in large part by Dr. Demetre Nicoloff of the University of Minnesota and St. Jude Medical employee Don Hanson.
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.
Old logo (1972-2018) The United States Consumer Product Safety Commission (USCPSC, CPSC, or commission) is an independent agency of the United States government.The CPSC seeks to promote the safety of consumer products by addressing "unreasonable risks" of injury (through coordinating recalls, evaluating products that are the subject of consumer complaints or industry reports, etc ...
What: Shares of medical device maker St. Jude. Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're ...
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]
Use of the device may cause serious injury, including blood loss, artery tears, unstable blood pressure, prevention of blood flow to the heart, or death, according to the FDA.
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.