Class 2 Device Recall Custodiol HTK Solution

• Date Initiated by Firm: January 09, 2024
• Date Posted: September 26, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3300-2024
• Recall Event ID: 95182
• 510(K)Number: K192408
• Product Classification: Set, perfusion, kidney, disposable - Product Code KDL
• Product: Custodiol HTK Solution, 500ml bottle. 10 per carton.
• Code Information: UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches)
• Recalling Firm/ Manufacturer: Dr Franz Koehler Chemie Gmbh; Werner-Von-Siemens-Str. 14-28; Bensheim Germany
• Manufacturer Reason for Recall: Potential for particles to be present in solution.
• FDA Determined 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 Any affected product should be withdrawn, and sales stopped.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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDL