Status
Ongoing
Drug Enforcement D-0259-2025
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Classification
Class I
Report Date
March 19, 2025
Termination Date
—
Product Information
- Product description
- BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
- Product quantity
- 205,440 applicators
- Reason for recall
- Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide and Canada
Location & Firm
- Recalling firm
- CareFusion 213, LLC
- Address
-
1550 Northwestern Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0259-2025
- Event ID
- 96262
- Recall initiation date
- February 14, 2025
- Center classification date
- March 7, 2025
- Code info
- Lot #: 3200240, Exp 6/30/2026
- More code info
- —