Home / Recalls / CareFusion 213, LLC / D-0267-2021

D-0267-2021 Class I Terminated

Recalled by CareFusion 213, LLC — El Paso, TX

Recall Details

Product Type
Drugs
Report Date
March 3, 2021
Initiation Date
July 7, 2020
Termination Date
September 29, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
280 cartons

Product Description

ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400

Reason for Recall

Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

Distribution Pattern

Distributed in Puerto Rico and Oman

Code Information

All lots including but not limited to the following lot distributed in Zone IV: Lot # 0192894, Exp. 06/30/2023; 9080812 Exp 03/31/2022

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-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-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-0349-2021 Class II — ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl a (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-0346-2021 Class I — ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl (March 19, 2021)