Device product
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
Z-1827-2022
Product summary
- Event
- Event 90793
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5571 US, 409 OUS
- Official record key
device-enforcement:Z-1827-2022
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: TSFB-35-80 (GPN G01315) UDI-DI 00827002270411 Lots 14751376 Expiration Date 25-05-2027 TSFB-35-145 (GPN G00691) UDI-DI 00827002006911 Lots Expiration Dates 14813687 27-06-2027 14831302 07-07-2027 14831303 07-07-2027 14831304 07-07-2027 14831305 07-07-2027 14831307 07-07-2027 14831308 07-07-2027 14831309 07-07-2027 14831310 07-07-2027 14831311 07-07-2027 14831313 07-07-2027 14842394 14-07-2027 14842395 14-07-2027 14842396 14-07-2027 14842397 14-07-2027 14842398 14-07-2027 14842399 14-07-2027 14842400 14-07-2027 14842401 14-07-2027 TSFB-35-200 (GPN G01095) UDI-DI 00827002010956 Lot/Expiration Date: 14816668 28-06-2027
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.