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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 ...
ICU Medical recalls tubes used in tracheostomy due to manufacturing defect. September 18, 2024 at 3:40 PM (Reuters) - The U.S. Food and Drug Administration, on Wednesday, classified the recall of ...
AMSTERDAM (Reuters) -Philips shares surged 35% early on Monday as the medical devices maker announced a smaller-than-expected settlement to resolve claims over recalled breathing devices in the ...
An example is the pharmaceutical company Avanos Medical, which in 2022 conducted a voluntary field correction after reports of 60 injuries and 23 patient deaths related to misplaced nasogastric feeding tubes while using their CORTRAK* 2 Enteral Access System. [10] The voluntary field correction led Avanos Medical to recall the product.
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.
Product recalls are one of a number of corrective actions that can be taken for products that are deemed to be unsafe. The recall is an effort to limit ruination of the corporate image and limit liability for corporate negligence, which can cause significant legal costs. It can be difficult, if not impossible, to determine how costly can be ...
The quarterly ExpertRECALL Index released today indicates that more than 123 million medical device units were recalled during the second quarter of 2012, an eight-quarter high. The medical device ...
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...