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10 Results Found

Baxter recalls Spectrum infusion pumps 

The Food and Drug Administration March 5 announced that Baxter Healthcare Corporation recalled its Spectrum infusion pumps due to the potential for missing motor mounting screws.

White House announces tariffs on steel and aluminum imports

The Trump administration yesterday announced it issued

Baxter alerts providers to potential high-risk issues with devices 

The Food and Drug Administration Dec. 31 released an alert highlighting a Baxter letter that recommended health care providers not use certain lots of Solution Sets with Duo-Vent Spikes due to a potentially high-risk issue.

FDA announces firm distributing Chinese-made plastic syringes in the U.S. initiates recall 

Medline Industries initiates recall of Chinese-made plastic syringes in the U.S.

FDA issues import alert, additional recommendations against using plastic syringes made in China 

The Food and Drug Administration yesterday announced an import alert for plastic syringes manufactured by two China-based manufacturers, in addition to recommendations against using any other Chinese-manufactured plastic syringes.

FDA clarifies definition of 'remanufacturing' for medical devices needing maintenance

The Food and Drug Administration May 9 released final guidance clarifying the definition of “remanufacturing” for reusable medical devic

FDA advises against using plastic syringes made in China

U.S. health care organizations should immediately transition away from using certain unauthorized plastic syringes made in China by Jiangsu Caina Medical Co. and Jiangsu Shenli Medical Production Co., and should only use other plastic syringes made in China until they can transition to alternatives, the Food and Drug Administration announced.

FDA approves combo test for flu, COVID-19; alerts providers to medical device risks 

The Food and Drug Administration recently granted emergency use authorization for the first over-the-counter home antigen test to detect both flu and COVID-19.

FDA adds vaporized hydrogen peroxide as an established medical device sterilization method 

In updated guidance for makers of medical devices labeled as sterile, the Food and Drug Administration Jan. 8 listed vaporized hydrogen peroxide as an established sterilization method for medical devices.