FDA recall D-0441-2025

CareFusion 213, LLC · Class II · drug

Product

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.

Distribution

Nationwide in the U.S.

Key facts

Status
Ongoing
Initiation date
2025-05-15
Report date
2025-05-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0441-2025