Cook Incorporated: Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607

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: 277 US; 138 OUS Lot/code info: RFSPC-35-145 G09607 UDI-DI: 00827002096073 Lot/Expiration Date: 14831437 07-07-2025 14831438 07-07-2025 14835040 11-07-2025 14840287 13-07-2025 14840288 13-07-2025 14840309 13-07-2025

UPC codes

00827002096073

Source

Official record: FDA (Device enforcement) ↗

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