ChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization
CareFusion 213, LLC is recalling 7,650 units of ChloraPrep One-Step antiseptic applicators distributed nationwide because unsterilized product intended for further processing was distributed through incorrect channels.
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 for a topical antiseptic product lacking assurance of sterility. The source text does not report any illnesses or injuries, but unsterilized antiseptic applicators intended for medical use present a significant risk of harm (infection) if used on patients; therefore the score is 4 per the rubric for Class II recalls with risk-of-harm products where injury has not yet been reported.
Plain-English summary
ChloraPrep One-Step (2% chlorhexidine gluconate and 70% isopropyl alcohol) applicators in 3 mL packages are being recalled by CareFusion 213, LLC. The product was manufactured for further processing and sterilization but was instead distributed to customers outside the intended distribution channel, creating a lack of assurance of sterility.
Approximately 7,650 units have been distributed nationwide. The affected product includes multiple lot numbers with expiration dates ranging from June 2026 through April 2028. Healthcare facilities and providers who have received this product should not use it and should contact CareFusion 213, LLC for instructions on return or disposal.
This is a Class II recall. Customers and healthcare providers should verify the lot numbers of any ChloraPrep One-Step applicators in their possession against the recall list and segregate any affected batches. For questions or to report any use of the recalled product, contact the manufacturer.
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
- microbial-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 (20)
- Lot: a) 3194046
- Exp. 06/30/2026
- 3217036
- Exp 07/31/2026
- 3279434
- Exp 09/30/2026
- 3286268
- 3304460
- Exp 10/31/2026
- 3346277
- Exp 11/30/2026
- 4031686
- 4039656
- Exp 01/31/2027
- 4048949
- 4060437
- 4067207
- Exp 02/28/2027
- 4092773
- 4094978
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CHLORAPREP ONE-STEP
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- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
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