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The U.S. Food and Drug Administration issued a Class I recall, the agency's most serious, for the Medfusion syringe pump, the third major FDA recall for the line of devices made in Oakdale. Smiths ...
There have been 51 complaints, one death related to this recall and one reported injury, the FDA said. B. Braun Medical did not immediately respond to a Reuters request for comment.
The recall occurred due to a software defect that may lead to mismatched drug information in drug lib Baxter Recalls Dose IQ Software 9.0.x Used With Infusion Pumps Skip to main content
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 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]
The recall by the U.S. Food and Drug Administration of one medical company's entire line of infusion pumps -- widely used to administer fluids to the human body -- has called attention to ...
The Emergency Severity Index (ESI) is a five-level emergency department triage algorithm, initially developed in 1998 by emergency physicians Richard Wurez and David Eitel. [1] It was previously maintained by the Agency for Healthcare Research and Quality (AHRQ) but is currently maintained by the Emergency Nurses Association (ENA). Five-level ...
An industry source familiar with medical device policy making told me that “companies make every effort” to ensure the products’ users and their physicians are aware of recalls and that the ...