Device product
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
Z-1343-2025
Product summary
- Event
- Event 96343
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1420
- Official record key
device-enforcement:Z-1343-2025
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 00191072219602 Lots 70-050707 70-050860 70-051149 70-051713 70-052363 70-053044
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.