BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl a...
FDA Recall #D-0259-2025 — Class I — February 14, 2025
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.
Reason for Recall
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Recalling Firm
CareFusion 213, LLC — El Paso, TX
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
205,440 applicators
Distribution
Nationwide and Canada
Code Information
Lot #: 3200240, Exp 6/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated