Drug recall D-0373-2021
Product
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.
Lots and codes
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
Recall details
- Recalling firm
- CareFusion 213, LLC, El Paso, TX
- Quantity
- 707,050 eaches
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 20, 2021
- Terminated
- June 21, 2023
Related products
- ChloraPrep One-Step – drug information
- NDC 54365-400 ChloraPrep One-Step · Chlorhexidine Gluconate 20 mg/mL; Isopropyl Alcohol .7 mL/mL · CareFusion 213, LLC