FDA recalls filters for potential of serious harm; voluntary notice issued for soaps, cleansers
The Food and Drug Administration has identified a Class I recall of Draeger SafeStar and TwinStar Filters due to a risk of misleading carbon dioxide readings. The readings could result in health care providers administering unnecessary or harmful treatments based on incorrect waveform interpretations. Using the affected filters could result in serious injury or death.
In addition, the FDA Aug. 9 released a notice on a voluntary DermaRite recall of its DermaKleen, Dermasarra, Kleenfoam and Perigiene products due to a microbial contamination that can result in serious and life-threatening infections.
Related News Articles
Headline
The AHA urged the Department of Commerce Oct. 17 to take a balanced approach to ensuring dependable and affordable access to personal protective equipment,…
Headline
The AHA’s Association for Health Care Resource & Materials Management has created a webpage featuring resources on tariffs impacting the health care supply…
Headline
The AHA provided a statement of record to the Senate Special Committee on Aging for a hearing Oct. 8 on the pharmaceutical and medical device supply chains.…
Headline
President Trump, late Sept. 25, announced that starting Oct. 1, the U.S. will impose a 100% tariff on any branded or patented pharmaceutical product, unless a…
Headline
The Department of Commerce Sept. 24 released a notice seeking public comment on an investigation it launched Sept. 2 on imports of personal protective…
Headline
The Food and Drug Administration has identified a Class I recall of certain Olympus ViziShot 2 FLEX Needles due to a possible patient safety issue caused by a…