Device product
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
Z-1340-2025
Product summary
- Event
- Event 96343
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 956 kits
- Official record key
device-enforcement:Z-1340-2025
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 00191072219510 Lots 70-050850 70-051285 70-051779 70-051779A 70-052186 70-052669 70-053022
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.