Z-3300-2024Class II

Custodiol HTK Solution, 500ml bottle. 10 per carton

Name: Z-3300-2024 Custodiol HTK Solution, 500ml bottle. 10 per carton
Creator: Dr Franz Koehler Chemie Gmbh
Published: 2024-01-09
License: https://open.fda.gov/license/

Dr. Franz Kohler Chemie GmbH / initiated 2024-01-09 / Open, Classified / root cause: design

FDA source

Dr Franz Koehler Chemie Gmbh began a recall of Custodiol HTK Solution, 500ml bottle. 10 per carton on 2024-01-09. FDA classified it as Class II and gives the reason as "Potential for particles to be present in solution". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-3300-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-09
Posted: 2024-09-26
Recalling firm: Dr. Franz Kohler Chemie GmbH
Product: Custodiol HTK Solution, 500ml bottle. 10 per carton.
Product code: KDL Set, Perfusion, Kidney, Disposable
Reason for recall: Potential for particles to be present in solution.
Root cause tag: design
FDA 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 Any affected product should be withdrawn, and sales stopped.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 in commerce: 48 cartons (480 bottles)
Distribution: US Nationwide distribution in the state of North Carolina.
Product codes and lots: UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3300-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3300-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26

Product code KDL

K192408Class IICustodiol HTK SolutionDr. Franz Kohler Chemie GmbH / cleared 2020-04-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)