ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, lacking 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: The FDA classified this as Class II, which typically warrants a Severe rating. Although no illnesses or injuries are reported in the source text, the recall involves a fundamental sterility assurance failure for a topical drug product intended for skin antisepsis in medical settings, representing a significant risk of harm.
Plain-English summary
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators distributed nationwide in the United States. The recall affects 146,600 units packaged as 100 x 3ml or 250 x 3ml applicators per case.
The recall was initiated because unsterilized ChloraPrep and PurPrep applicators, which were intended for further processing and sterilization, were instead distributed to customers outside of the intended distribution channel. This creates a lack of assurance of sterility for the affected product.
Affected lot numbers and expiration dates are specified in the product information. Customers who received these applicators should contact CareFusion 213, LLC for instructions on handling the recalled product. Healthcare facilities and other users should verify whether they have received affected lots and discontinue use of any recalled units.
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
- sterility-assurance
- contamination-risk
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) 3214024
- 3199359
- 3200136
- Exp 6/30/2026
- 3212372
- Exp. 7/31/2026
- 3237018
- 3243267
- 3264290
- Exp. 8/31/2026
- 3313291
- Exp. 10/31/2026
- 3334121
- Exp. 11/30/2026
- 4030693
- 4033380
- Exp 1/31/2027
- 4058103
- 4065931
- Exp. 2/28/2027
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
- 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
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Loss
FDA (Drugs) · 2026-07-08
- 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 Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08
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