Custodiol HTK Solution, 500ml bottle. 10 per carton recallZ-3300-2024 · Dr Franz Koehler Chemie Gmbh · initiated Jan 9, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Dr Franz Koehler Chemie Gmbh or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for particles to be present in solution.
FDA root cause category: Device Design
What the company is doing
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 Any affected product should be withdrawn, and sales stopped.
Recall details
- Recall number
- Z-3300-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 9, 2024
- Posted by the FDA
- Sep 26, 2024
- Recalling firm
- Dr Franz Koehler Chemie Gmbh
- Quantity
- 48 cartons (480 bottles)
- Product code
- KDL
- FDA submissions
- K192408
- Distribution
- US Nationwide distribution in the state of North Carolina.
Product description
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Code information (models, lots, serial numbers)
UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Custodiol(R) 10 x 500 mlDr. Franz Köhler Chemie GmbH · System, Perfusion, Kidney1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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