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FDAAugust 16, 2022device

Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561

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

The hazard

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

What to do

FDA enforcement status: Ongoing

Brands named

cook

UPCs

0082700200701700827002005617

Recall history

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

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