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
- Affected units
- 400
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.
Part of a larger recall action
This product is one of 10 recalled by CareFusion 213, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same brand · CHLORAPREP ONE-STEP
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
Same manufacturer · CareFusion 213, LLC
See all →- SeverePurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15