FDA Announces Class I Recall on Nephros’ SafeSpout, SafeShower

The U.S. Food and Drug Administration has announced a Class I recall on River Edge, N.J.-based Nephros SafeSpout and SafeShower water filtration faucets due to a potentially faulty filter that could expose patients to harmful bacteria or viruses.

Advertisement

The SafeSpout and SafeShower faucets are intended to filter harmful bacteria and viruses out of hospitals’ water supply. If the sealing compound of the faucets breaks, patients may be exposed to harmful bacteria or viruses, potentially resulting in infection or death.

One reported death and one reported infection have been associated with this recall, according to the news release.

More Articles on the FDA:

9 Ophthalmology Devices Receive FDA 510(k) Clearance in November & December
Delphinus Medical Technologies Announced FDA Clearance for Breast Imaging System
6 GI/Endoscopy-Related Devices Receive FDA 510(k) Clearance in December

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

Advertisement

Next Up in Uncategorized

Advertisement

Comments are closed.