FDA-Drug2021-05-19Class I
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
Hazard
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Sold states
Nationwide within the United States
Affected count
707,050 eaches
Manufactured in
1550 Northwestern Dr, El Paso, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0373-2021More CareFusion 213, LLC recalls
- FDA-Drug2026-07-01BD ChloraPrep Clear skin antiseptic recalled for sterility assurance due to packaging defect
- FDA-Drug2026-07-01BD ChloraPrep FREPP Clear skin antiseptic recalled for potential sterility breach
- FDA-Drug2026-07-01BD ChloraPrep Clear antiseptic solution recalled for non-sterility due to fungal contamination
- FDA-Drug2026-07-01BD ChloraPrep FREPP Clear skin antiseptic recalled for non-sterility and potential contamination
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