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FDAAugust 16, 2022device

Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261

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

00827002016231008270020177400082700201264600827002012615

Recall history

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

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