Recall Z-3300-2024 ยท KDL Set, Perfusion, Kidney, Disposable
Dr Franz Koehler Chemie Gmbh
Custodiol HTK Solution, 500ml bottle. 10 per carton.
| Date | Sep 26, 2024 (initiated Jan 9, 2024) |
| Status | Open, Classified |
| Reason | Potential for particles to be present in solution. |
| Root cause | Device Design |
| 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 Any affected product should be withdrawn, and sales stopped. |
| Quantity | 48 cartons (480 bottles) |
| Distribution | US Nationwide distribution in the state of North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192408 | Custodiol HTK Solution Dr. Franz Kohler Chemie GmbH, Apr 24, 2020 |