FDA Medical Device Recalls (openFDA)
Dr Franz Koehler Chemie Gmbh: Custodiol HTK Solution, 500ml bottle. 10 per carton.
- Recall number
- Z-3300-2024
- Recalling firm
- Dr Franz Koehler Chemie Gmbh
- Product
- Custodiol HTK Solution, 500ml bottle. 10 per carton.
- Status
- Open, Classified
- Initiated
- 2024-01-09
- Posted
- 2024-09-26
- Terminated
- not on file
- Reason
- Potential for particles to be present in solution.
- 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 Any affected product should be withdrawn, and sales stopped.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
- 48 cartons (480 bottles)
- Distribution
- US Nationwide distribution in the state of North Carolina.
- Lot, serial or model codes
- UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches)
- 510(k) numbers
- ["K192408"]
- PMA numbers
- not on file
- Product code
- KDL
- Firm FEI
- 3001640191
- Firm city
- Bensheim
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28