Device product
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Z-1264-2024
Product summary
- Event
- Event 94026
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18 units (US); 5 units (OUS)
- Official record key
device-enforcement:Z-1264-2024
Official wording
Reason: Potential packaging breaches of inner blister and outer sterile blister.
Code information: Part No. 5537-G-411-E; GTIN: 07613327287691; Lot No. E97TH6; Expiration Date: 10/07/2028.
Distribution pattern: Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
Derived failure modes
-
Unknown
Potential packaging breaches of inner blister and outer sterile blister.