Z-3300-2024 Class II Ongoing
FDA device recall Z-3300-2024 was initiated by Dr Franz Koehler Chemie Gmbh on January 9, 2024 and is designated Class II. Reason for recall: Potential for particles to be present in solution. The recall status is ongoing. Affected quantity: 48 cartons (480 bottles).
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- January 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 cartons (480 bottles)
Product Description
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Reason for Recall
Potential for particles to be present in solution.
Distribution Pattern
US Nationwide distribution in the state of North Carolina.
Code Information
UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches)