Device product
Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
Z-1845-2022
Product summary
- Event
- Event 90793
- Status
- Ongoing
- Classification
- Class II
- Quantity
- No distribution (Distribution Center only)
- Official record key
device-enforcement:Z-1845-2022
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: THSF-35-125-THG G27031 UDI-DI: 00827002270312 Lot/Expiration Date: 14804788 21-06-2027 THSF-35-145-THG G27033 UDI-DI: 00827002270336 Lots/Expiration dates: 14804789 21-06-2027 NS14804743 21-06-2027
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.