CareFusion Recalls ChloraPrep Applicators Due to Sterility Concerns
CareFusion is recalling 23,000 ChloraPrep applicators because immediate product pouches may not be properly sealed, potentially compromising sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from non-sterile medical devices.
Plain-English summary
CareFusion 213, LLC is recalling 23,000 units of ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL applicators. The specific lot number is 71132, with an expiration date of 02/2017. The product is distributed nationwide in the U.S.
The recall was initiated due to a lack of assurance of sterility. Specifically, the immediate product pouches may not be properly sealed, which could compromise the sterile status of the applicators.
Healthcare providers and facilities should stop using the affected product and contact CareFusion for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
- Manufacturer
- CareFusion 213, LLC
- Category
- Medical Device — Surgical Prep
- Affected units
- 23,000
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 (2)
- Lot #: 71132
- Expiry: 02/2017
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · CareFusion 213, LLC
See all →- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall
FDA (Drugs) · 2026-07-08
- SevereChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization
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 Sterile Assurance
FDA (Drugs) · 2026-07-08
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- CriticalCareFusion Recalls ChloraPrep Applicators Due to Non-Sterility
FDA (Drugs) · 2020-08-26
- HighCareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk
FDA (Drugs) · 2021-05-05
- SevereCareFusion Recalls ChloraPrep Antiseptic Due to Fungal Contamination
FDA (Drugs) · 2021-05-05
- SevereCarefusion Recalls ChloraPrep Applicators Due to Incomplete Seals
FDA (Drugs) · 2012-09-26
- SevereCareFusion Recalls Non-Sterile ChloraPrep Solution Due to Microbial Contamination Risk
FDA (Drugs) · 2021-03-03
- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-08