ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterile drug product distributed without the required sterilization assurance. The hazard—use of unsterilized topical applicators intended for direct patient contact—creates risk of serious adverse health consequences including infection, even though no reported illnesses are stated in the source.
Plain-English summary
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators distributed nationwide in the USA. The applicators were intended for further processing and sterilization before use, but unsterilized units were instead distributed to customers outside the intended distribution channel.
The affected product is ChloraPrep FREPP, Clear, 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol, supplied as 500 x 1.5 mL applicators per case. The recall affects approximately 10,500 units across multiple lots with expiration dates ranging from September 2026 through April 2028.
Customers who received these applicators should stop using them immediately and contact CareFusion 213, LLC for instructions on return or destruction. Healthcare facilities and medical professionals should verify that ChloraPrep One-Step applicators have been properly sterilized before use in any patient care setting.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- lack-of-sterility
- defective-sterilization-process
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 (20)
- Lot: 3279063
- Exp. 9/30/2026
- 3319524
- 3324094
- 3343541
- Exp. 11/30/2026
- 3357638
- 4010202
- Exp. 12/31/2026
- 4206771
- Exp. 7/31/2027
- 4267824
- 4270191
- 4282285
- Exp.9/30/2027
- 4338352
- Exp. 11/30/2027
- 5053657
- Exp. 2/29/2028
- 5121340
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CHLORAPREP ONE-STEP
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
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- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
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