Home / Recalls / CareFusion 213, LLC / D-0373-2021

D-0373-2021 Class I Terminated

Recalled by CareFusion 213, LLC — El Paso, TX

Recall Details

Product Type
Drugs
Report Date
May 19, 2021
Initiation Date
April 20, 2021
Termination Date
June 21, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
707,050 eaches

Product Description

BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-38

Reason for Recall

Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 0108186, Exp. 4/30/2023; 0327867, 0327868, 0328213, 0338656, 0339071, 0328947, 0328949, 0329475, 0329477, 0330457, 0330955, 0330606 0333826, 0333852, 0333855, 0334119, 0335787, 0335792, 0335029, 0336506 0336972, 0336051, 0337245, 0337025, 0338653, 0338542, 0338852, 0339892 0339457, Exp. 11/30/2023

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-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)