ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators that were intended for sterilization but were instead distributed unsterilized to customers outside the intended distribution channel.
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: FDA classified this as Class II, and the hazard involves lack of sterility assurance for a topical drug product intended for use on skin, which presents a significant risk of infection and harm. Class II recalls with risk of serious health consequences meet the Severe threshold.
Plain-English summary
CareFusion 213, LLC is recalling BD ChloraPrep Hi-Lite Orange applicators (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) packaged as 100 x 10.5 mL applicators per case. The recall affects 1,800 units nationwide.
The recalled product was intended for further processing and sterilization before use. However, unsterilized applicators were distributed to customers outside of the intended distribution channel, creating a lack of assurance of sterility.
The recalled lot numbers are: 3362296 (expires 12/31/2026), 4066870 (expires 02/28/2027), 4104107 (expires 03/31/2027), 4276125 (expires 09/30/2027), 4080695 (expires 03/31/2027), and 4233300 (expires 08/31/2027). Customers who have received these products should contact CareFusion 213, LLC for instructions on proper handling and replacement.
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 (10)
- Lot: a) 3362296
- expires: 12/31/2026
- 4066870
- expires: 02/28/2027
- 4104107
- expires: 03/31/2027
- 4276125
- expires: 09/30/2027
- b) 4080695
- 4233300 expires: 08/31/2027.
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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- SevereChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance
FDA (Drugs) · 2026-07-08
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