Device product
LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
Z-1337-2025
Product summary
- Event
- Event 96343
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 630 kits
- Official record key
device-enforcement:Z-1337-2025
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 00191072219206 Lots 882241 70-051163 70-051373 70-051564 70-052582 70-053048
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.