Cook Incorporated: 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

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: 1,236 US Lot/code info: THSF-35-145-COONS G02356 UDI-DI 00827002023567 Lot/Expiration Date 14757818 27-05-2027 14795059 15-06-2027 14797781 16-06-2027 14802363 20-06-2027 THSF-38-145-COONS G02324 UDI-DI 00827002023246 Lot/Expiration Date 14793057 14-06-2027 THSF-35-180-COONS G02621 UDI-DI 00827002026216 Lot/Expiration Date 14797773 16-06-2027 THSF-35-80-COONS G12268

UPC codes

00827002023567, 00827002023246, 00827002026216

Source

Official record: FDA (Device enforcement) ↗

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