Dr Franz Koehler Chemie Gmbh: Medical Device Recall in 2024 - (Recall #: Z-3300-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Custodiol HTK Solution, 500ml bottle. 10 per carton.

Product Classification:

Class II

Date Initiated: January 9, 2024

Date Posted: October 2, 2024

Recall Number: Z-3300-2024

Event ID: 95182

Reason for Recall:

Potential for particles to be present in solution.

Status: Ongoing

Product Quantity: 48 cartons (480 bottles)

Code Information:

UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches)

Distribution Pattern:

US Nationwide distribution in the state of North Carolina.

Voluntary or Mandated:

Voluntary: Firm initiated