Device product
Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
Z-1832-2022
Product summary
- Event
- Event 90793
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 58 US; 5 OUS
- Official record key
device-enforcement:Z-1832-2022
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: THSCF-25-180-3 G02165 UDI-DI: 00827002021655 Lots/Expiration Dates: 14797761 16-06-2027 14813704 27-06-2027 TSCF-25-80-3 G00476 UDI-DI: 00827002004764 Lots/Expiration Dates: NS14797766 16-06-2027 NS14807600 22-06-2027 NS14821727 30-06-2027
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.