Device product
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Z-1349-2025
Product summary
- Event
- Event 96343
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 690 kits
- Official record key
device-enforcement:Z-1349-2025
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 00191072135063 00191072223715 Lots 899241 70-050880 70-051697 70-052161 70-052662
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.