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
CareFusion 213, LLC
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-0373-2021Don't want to check this manually?
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