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FDAJanuary 4, 2019device

PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10

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

The hazard

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

What to do

FDA enforcement status: Terminated

Brands named

cook

UPCs

63881363541310

Recall history

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

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PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10 — Recall Details · AllClear