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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
Related recalls
Same hazard · particle contamination
See all →- ModerateCyproheptadine Hydrochloride Syrup Recall Due to Precipitate
FDA (Drugs) · 2026-07-29
- HighBD Vacutainer Luer Lok Access Device may shed particles causing false test results
FDA (Devices) · 2022-03-02
- HighOrthopedic drill bit recalled for corrosion particle contamination risk
FDA (Devices) · 2021-08-18
- ModerateEthicon 5mm Endopath Xcel Trocar Recalled for Insufficient Lubrication
FDA (Devices) · 2018-05-23
Similar recalls
- HighLidocaine Injectable Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2023-05-31
- HighCalcium Chloride Injectable Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2022-07-20
- LowActavis Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities
FDA (Drugs) · 2016-08-31
- HighInjectable Drug Recalled for Sterility Concerns Due to Manufacturing Defects
FDA (Drugs) · 2022-04-27
- ModerateHycor Biomedical Recalls Leaking HYTEC Stop Solution Bottles
FDA (Devices) · 2019-11-06
- SevereFDA Recalls Injectable Glutathione Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12