Cook Incorporated: Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677

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: N/A Lot/code info: TMT-35-145 G01677 UDI-DI: 00827002016774 Lot/Expiration Date: 14808818 22-06-2027

UPC codes

00827002016774

Source

Official record: FDA (Device enforcement) ↗

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