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FDAOctober 22, 2020device

Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications.

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

The hazard

Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.

What to do

FDA enforcement status: Terminated

Brands named

cook

UPCs

00827002005174

Recall history

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

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Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and other medical devices in vascular applications. — Recall Details · AllClear