Status
Ongoing
Drug Enforcement D-0441-2025
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Classification
Class II
Report Date
May 28, 2025
Termination Date
—
Product Information
- 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.
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the U.S.
Location & Firm
- Recalling firm
- CareFusion 213, LLC
- Address
-
1550 Northwestern Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0441-2025
- Event ID
- 96879
- Recall initiation date
- May 15, 2025
- Center classification date
- May 20, 2025
- Code info
- Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
- More code info
- —