PlainRecalls
FDA Drug Moderate Class II Ongoing

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.

Reported: May 28, 2025 Initiated: May 15, 2025 #D-0441-2025

Product Description

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.

Reason for Recall

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

Details

Recalling Firm
CareFusion 213, LLC
Units Affected
385,200 applicators
Distribution
Nationwide in the U.S.
Location
El Paso, TX

Frequently Asked Questions

What product was recalled?
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.. Recalled by CareFusion 213, LLC. Units affected: 385,200 applicators.
Why was this product recalled?
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 28, 2025. Severity: Moderate. Recall number: D-0441-2025.