Cook Incorporated: Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)

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: 488 US, 5 OUS Lot/code info: TSFBP-35-180 (GPN G09782) UDI-DI 00827002097827, Lots 14797763 14797770 14805076 14805079 14813709 14813711; TSFBP-35-145 (GPN G09735) UDI-DI 00827002097353, Lots 14807595 14812037 14812038

UPC codes

00827002097827, 00827002097353

Source

Official record: FDA (Device enforcement) ↗

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