BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Pa...
FDA Recall #D-0441-2025 — Class II — May 15, 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.
Recalling Firm
CareFusion 213, LLC — El Paso, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
385,200 applicators
Distribution
Nationwide in the U.S.
Code Information
Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated