Home / Recalls / CareFusion 213, LLC / D-0259-2025

D-0259-2025 Class I Ongoing

Recalled by CareFusion 213, LLC — El Paso, TX

Recall Details

Product Type
Drugs
Report Date
March 19, 2025
Initiation Date
February 14, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
205,440 applicators

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.

Distribution Pattern

Nationwide and Canada

Code Information

Lot #: 3200240, Exp 6/30/2026

Other recalls by CareFusion 213, LLC

  • D-0243-2026 Class II — BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isop (December 17, 2025)
  • D-0441-2025 Class II — BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl (May 15, 2025)
  • D-1168-2023 Class II — BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl (August 25, 2023)
  • D-0373-2021 Class I — BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (C (April 20, 2021)
  • D-0343-2021 Class I — BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl (March 19, 2021)
  • D-0350-2021 Class II — ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl (March 19, 2021)
  • D-0347-2021 Class II — BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl (March 19, 2021)
  • D-0346-2021 Class I — ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl (March 19, 2021)
  • D-0349-2021 Class II — ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl a (March 19, 2021)
  • D-0344-2021 Class I — BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v is (March 19, 2021)