Custodiol HTK Solution, 500ml bottle. 10 per carton.
FDA device recall Z-3300-2024 · posted 2024-09-26 · Open, Classified
Recall details
- Recalling firm
- Dr Franz Koehler Chemie Gmbh
- Reason for recall
- Potential for particles to be present in solution.
- 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 Any affected product should be withdrawn, and sales stopped.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KDL
- Quantity affected
- 48 cartons (480 bottles)
- Distribution
- US Nationwide distribution in the state of North Carolina.
- Date initiated
- 2024-01-09
- Date posted
- 2024-09-26
- Location
- Bensheim, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Custodiol HTK Solution (K192408) | Dr. Franz Kohler Chemie GmbH | 2020-04-24 |