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FDAMay 25, 2022device

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream which may result in pulmonary embolism or ischemia.

What to do

FDA enforcement status: Completed

Brands named

cook

UPCs

00827002028388

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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