Device product
EAR PACK , Model No SFEA12A
Z-1351-2025
Product summary
- Event
- Event 96343
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 51 kits
- Official record key
device-enforcement:Z-1351-2025
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 00191072167446 Lots 968241 888241 70-052114 70-052727 70-053132
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.