ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators distributed nationwide because unsterilized units intended for further processing were shipped 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 Class II recall with a significant safety issue: unsterilized topical applicators intended for medical use were distributed outside proper channels, creating potential for contamination or infection in patients. Although no illnesses are reported in the source, the lack of sterility assurance in products meant for medical use meets the Class II severity threshold.
Plain-English summary
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v) applicators. The affected products were intended for further processing and sterilization but were instead distributed to customers outside the intended distribution channel, creating a lack of assurance of sterility.
The recalled product is BD ChloraPrep Scrub Teal, packaged as 100 x 10.5 mL applicators per case. A total of 1,200 units were distributed nationwide in the USA. Multiple lot numbers are affected with varying expiration dates.
Customers who have received these applicators should not use them and should contact CareFusion 213, LLC with questions about the recall. The FDA classified this as a Class II recall.
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
- improper-distribution
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 (18)
- Lot: a) 4157798
- Exp 05/31/2027
- 5016842
- Exp 12/31/2027
- 5112542
- Exp 04/30/2028 b) 3330777
- Exp 10/31/2026
- 3345111
- Exp 12/31/2026
- 4037991
- Exp 01/31/2027
- 4114505
- Exp 04/30/2027
- 4156664
- 4270441
- Exp 09/30/2027
- 5078395
- 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
- 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 Antiseptic Applicators recalled for lack of sterility assurance
FDA (Drugs) · 2026-07-08
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereAccucaine Lidocaine Injection Recalled for Lack of Sterility Assurance
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 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