FDAHealthFebruary 14, 2025
CareFusion 213, LLC — 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. o
⚠️ Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 14, 2025
Nationwide and Canada
What's affected?
- Product
- 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.
- Brand
- CHLORAPREP ONE-STEP
- Lot code
- 3200240
Additional details
Lot #: 3200240, Exp 6/30/2026
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 205,440 applicators.
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