Device product
Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part Number/GPN: TSFNA-35-145 G00701 TSCFNA-35-145-3 G00561
Z-1836-2022
Product summary
- Event
- Event 90793
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 42 US
- Official record key
device-enforcement:Z-1836-2022
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: TSFNA-35-145 G00701 UDI-DI: 00827002007017 Lots/Expiration Date: 14798674 16-06-2027 TSCFNA-35-145-3 G00561 UDI-DI: 00827002005617 Lots/Expiration Date: 14835600 11-07-2027
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.