Device product
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Z-3300-2024
Product summary
- Event
- Event 95182
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48 cartons (480 bottles)
- Official record key
device-enforcement:Z-3300-2024
Official wording
Reason: Potential for particles to be present in solution.
Code information: UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches)
Distribution pattern: US Nationwide distribution in the state of North Carolina.
Derived failure modes
-
Unknown
Potential for particles to be present in solution.