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.
This recall is currently active, issued May 28, 2025. It was issued by Carefusion 213, Llc.
- Company
- Carefusion 213, Llc
- Recall Initiated
- May 15, 2025
- Posted
- May 28, 2025
- Recall Number
- D-0441-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 385,200 applicators
- Firm Location
- El Paso, TX, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
More recalls by Carefusion 213, Llc
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA),...
Jan 7, 2026 · Class II
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alco...
Mar 19, 2025 · Class I
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Steril...
Sep 27, 2023 · Class II
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