CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report
Custodiol HTK Solution recalled by Dr Franz Koehler Chemie
Dr Franz Koehler Chemie is recalling Custodiol HTK Solution, distributed nationwide in the US. The recall was initiated on 9 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3300-2024
- FDA event ID
- 95182
- Recalling firm
- Dr Franz Koehler Chemie, Bensheim
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jan 2024
- FDA classified
- 26 Sep 2024
- Reported
- 2 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Particulate Matter
- Device type
- Contact Lenses & Eye Devices
Timeline
| 9 Jan 2024 | Recall initiated by company | |
| 26 Sep 2024 | Classified by FDA | +261 days |
| 2 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for particles to be present in solution.
Product as listed by the FDA
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Where it was distributed
US Nationwide distribution in the state of North Carolina.
Questions about this recall
Why was it recalled?
Potential for particles to be present in solution.
Which lots are affected?
UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches)
Where was it sold?
US Nationwide distribution in the state of North Carolina.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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