FDA Device recall Z-3300-2024
Custodiol HTK Solution, 500ml bottle. 10 per carton
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of Custodiol HTK Solution, 500ml bottle. 10 per carton by Dr Franz Koehler Chemie, citing potential for particles to be present in solution.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3300-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-09 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Dr Franz Koehler Chemie |
| Distribution | US |
Product
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Reason
Potential for particles to be present in solution.
Identifiers
| code_info | UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3300-2024%22
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