Device product
THORACIC PACK , Model No UTTC82Y UTTC82AA-01
Z-1361-2025
Product summary
- Event
- Event 96343
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 40 kits
- Official record key
device-enforcement:Z-1361-2025
Official wording
Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Code information: UDI-DI 00191072147332 Lots 954241 921241 889241 70-051283 70-052001 70-052096 70-053233
Distribution pattern: US Nationwide distribution in the state of OH.
Derived failure modes
-
Unknown
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.