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FDA (Device enforcement)Recalled 2022-08-16class ii

Cook Incorporated: Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033

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.

Details from the source

Reason for recall: 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. Distribution: Domestic distribution nationwide. Foreign distribution worldwide. Quantity: No distribution (Distribution Center only) Lot/code info: THSF-35-125-THG G27031 UDI-DI: 00827002270312 Lot/Expiration Date: 14804788 21-06-2027 THSF-35-145-THG G27033 UDI-DI: 00827002270336 Lots/Expiration dates: 14804789 21-06-2027 NS14804743 21-06-2027

UPC codes

00827002270312, 00827002270336

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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