FDAHealthMay 15, 2025
CareFusion 213, LLC — 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 p
⚠️ Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 15, 2025
Nationwide in the U.S.
What's affected?
- 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.
- Brand
- CHLORAPREP ONE-STEP
- Lot code
- 3354127
Additional details
Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 385,200 applicators.
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