ChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance
CareFusion is recalling ChloraPrep One-Step antiseptic applicators because unsterilized units intended for further processing were distributed outside the intended channel, creating a sterility assurance gap.
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 with a critical quality defect (lack of sterility assurance). Unsterilized applicators intended for topical use on skin present a significant risk of infection and contamination, meeting the criteria for Severe classification.
Plain-English summary
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v) sterile solution applicators distributed nationwide. The applicators affected include lot numbers 3291614, 4034080, 4036599, 4081350, 5008234, 2320053, 4151258, and 5084224 in 26 mL single-use formats.
The recall was initiated because unsterilized ChloraPrep applicators, which were intended for further processing and sterilization before use, were instead distributed to customers outside of the intended distribution channel. This distribution error creates a lack of assurance regarding product sterility.
Customers who have received affected units should stop using them and contact CareFusion 213, LLC for instructions on return or disposal. Healthcare facilities and customers should verify lot numbers and expiration dates against the recalled lots listed in this notice.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- 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 (13)
- Lot: a) 3291614
- Exp 10/31/2026
- 4034080
- 4036599
- Exp 01/31/2027
- 4081350
- Exp 03/31/2027
- 5008234
- Exp 12/31/2027. b) 2320053
- Exp 11/30/2025
- 4151258
- Exp 05/31/2027. 5084224
- Exp 03/31/2028.
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CHLORAPREP ONE-STEP
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
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- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
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