Device product
Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
Z-1839-2022
Product summary
- Event
- Event 90793
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 202 US; 11 OUS
- Official record key
device-enforcement:Z-1839-2022
Official wording
Reason: 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.
Code information: RFPC-35-145 G07914 UDI-DI: 00827002079144 Lots/Expiration Date: 14828624 06-07-2025 14828638 06-07-2025 14837046 12-07-2025 NS14828650 06-07-2025
Distribution pattern: Domestic distribution nationwide. Foreign distribution worldwide.
Derived failure modes
-
Unknown
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.