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FDAMay 1, 2017device

Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture ne...

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

The hazard

COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

What to do

FDA enforcement status: Terminated

Brands named

cook

Recall history

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

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