Custodiol HTK Solution, 500ml bottle. 10 per carton.
This recall is currently active, issued September 26, 2024. It was issued by Dr Franz Koehler Chemie Gmbh Werner-Von-Siemens-Str. 14-28 Bensheim Germany.
- Recall Initiated
- January 9, 2024
- Posted
- September 26, 2024
- Recall Number
- Z-3300-2024
- Quantity
- 48 cartons (480 bottles)
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for particles to be present in solution.
Distribution
US Nationwide distribution in the state of North Carolina.
Lot / Code Info
UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches)
Root Cause
Device Design
Action Taken
The single distributor was notified on 01/09/2024 via email. The customer was instructed to notify customers and provide the recall letter. Any affected product should be withdrawn, and sales stopped.