Custodiol HTK Solution, 500ml bottle. 10 per carton.
FDA Recall Z-3300-2024 · Posted 2024-09-26
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Recalling FirmDr Franz Koehler Chemie Gmbh
Recall StatusOpen, Classified
Product CodeKDL
Date Initiated2024-01-09
Product Quantity48 cartons (480 bottles)
Reason for Recall
Potential for particles to be present in solution.
Firm 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 Any affected product should be withdrawn, and sales stopped.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the state of North Carolina.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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