CareFusion 213, LLC: Drug Recall
Recall #D-0441-2025 · 05/15/2025
Class II: Risk
Recall Details
- Recall Number
- D-0441-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- CareFusion 213, LLC
- Status
- Ongoing
- Date Initiated
- 05/15/2025
- Location
- El Paso, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 385,200 applicators
Reason for Recall
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
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.
Distribution Pattern
Nationwide in the U.S.
Other Recalls by CareFusion 213, LLC
- Class II: Risk 12/17/2025
- Class I: Dangerous 02/14/2025
- Class II: Risk 08/25/2023
- Class I: Dangerous 04/20/2021
- Class I: Dangerous 03/19/2021
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.