Custodiol HTK Solution Recalled for Potential Particle Contamination
Custodiol HTK Solution is subject to a Class II recall due to the potential for particles in the solution. The affected product consists of 48 cartons distributed in North Carolina.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall concerns potential particle contamination in a medical solution. Although no illnesses or injuries are reported in the source, the potential for particle contamination in a medical device represents a risk of harm that warrants a High severity designation per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Custodiol HTK Solution is subject to a Class II recall by the FDA. The affected product comprises 48 cartons containing 480 bottles of 500ml Custodiol HTK Solution.
The recall is issued due to the potential for particles to be present in the solution.
The affected batch numbers are 2314212, 2320012, 2322812, and 2333512. The product was distributed in North Carolina.
Healthcare facilities and providers with affected batches should discontinue use and contact Dr Franz Koehler Chemie Gmbh for instructions on return or disposal.
The recalled product
- Product
- Custodiol HTK Solution, 500ml bottle. 10 per carton.
- Manufacturer
- Dr Franz Koehler Chemie Gmbh
- Category
- Medical Device
- Hazard
- particle-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 04033133105003
- Batch Numbers: 2314212
- 2320012
- 2322812
- 2333512 (all batches)
Distribution
Distributed nationwide across the United States.
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