Dr Franz Koehler Chemie Gmbh: Custodiol HTK Solution Recalled for Potential Particulate Contamination

Agency Publication Date: September 26, 2024

Summary

Approximately 480 bottles (48 cartons) of Custodiol HTK Solution, a preservation solution used during organ transplants and cardiac procedures, are being recalled because they may contain foreign particles. If these particles are present in the solution and enter a patient's bloodstream, they could cause serious health complications. This recall affects 500ml bottles distributed specifically to medical facilities in North Carolina.

Risk

The presence of particles in an injectable or perfusion solution can lead to blockages in small blood vessels, inflammation, or more severe systemic reactions when introduced into the body during surgery.

What You Should Do

Identify if you have the affected Custodiol HTK Solution by checking the 500ml bottles for Batch Numbers 2314212, 2320012, 2322812, or 2333512.
Verify the UDI-DI code 04033133105003 on the product packaging to confirm it matches the recalled units.
Immediately stop using any bottles from the affected batches and quarantine the product to prevent accidental use.
Contact your healthcare provider or the manufacturer, Dr Franz Koehler Chemie Gmbh, for further instructions regarding the return or disposal of the affected bottles and potential product replacement.
For additional information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Custodiol HTK Solution (500ml bottle)

Model / REF:

UDI-DI: 04033133105003

Lot Numbers:

2314212

2320012

2322812

2333512

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95182

Status: Active

Manufacturer: Dr Franz Koehler Chemie Gmbh

Sold By: Medical facilities in North Carolina

Manufactured In: Germany

Units Affected: 48 cartons (480 bottles)

Distributed To: North Carolina

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected Custodiol HTK Solution by checking the 500ml bottles for Batch Numbers 2314212, 2320012, 2322812, or 2333512.

Verify the UDI-DI code 04033133105003 on the product packaging to confirm it matches the recalled units.

Immediately stop using any bottles from the affected batches and quarantine the product to prevent accidental use.

Contact your healthcare provider or the manufacturer, Dr Franz Koehler Chemie Gmbh, for further instructions regarding the return or disposal of the affected bottles and potential product replacement.

For additional information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.