Home / Recalls / CareFusion 213, LLC / D-0441-2025

D-0441-2025 Class II Ongoing

Recalled by CareFusion 213, LLC — El Paso, TX

Recall Details

Product Type
Drugs
Report Date
May 28, 2025
Initiation Date
May 15, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
385,200 applicators

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.

Reason for Recall

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

Distribution Pattern

Nationwide in the U.S.

Code Information

Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026

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-0259-2025 Class I — BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70 (February 14, 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-0346-2021 Class I — ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl (March 19, 2021)
  • D-0343-2021 Class I — BD ChloraPrep Clear, 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-0350-2021 Class II — 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)