Cook Incorporated: Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304

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: 149 US Lot/code info: STF-18-40-AUST G07304 UDI-DI: 00827002073043 Lots/Expiration Date: 14788615 13-06-2027 14816230 28-06-2027 14836977 12-07-2027

UPC codes

00827002073043

Source

Official record: FDA (Device enforcement) ↗

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