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FDAAugust 16, 2022device

Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268

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

008270020235670082700202324600827002026216

Recall history

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

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Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268 — Recall Details · AllClear