FDA Recall
Open, Classified
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Recall: Z-3300-2024
·
Initiated January 9, 2024
Recall
- Recall Number
- Z-3300-2024
- Event Number
- 95182
- Firm
- Dr Franz Koehler Chemie Gmbh Werner-Von-Siemens-Str. 14-28 Bensheim Germany
- FEI Number
- 3001640191
- Product Code
- KDL
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- January 9, 2024
- Posted
- September 26, 2024
Description
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Reason
Potential for particles to be present in solution.
Action
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 Any affected product should be withdrawn, and sales stopped.
Distribution
US Nationwide distribution in the state of North Carolina.
Quantity
48 cartons (480 bottles)