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The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...
The manufacturing defect was corrected in 2017, but devices distributed before the correction may still be in use, according to the FDA. US FDA classifies recall of Vyaire Medical's respiratory ...
The FDA has announced over 20 recalls across the U.S., including food items, cosmetics, drugs, dietary supplements, and medical devices.
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]
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
On Wednesday, ICU Medical Inc’s (NASDAQ:ICUI) subsidiary, Smiths Medical, initiated a recall of certain Bivona neonatal/pediatric and adult tracheostomy tubes. The FDA classified the recall as ...
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.
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.