PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: May 19, 2021 Initiated: April 20, 2021 #D-0373-2021

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.

Details

Recalling Firm
CareFusion 213, LLC
Units Affected
707,050 eaches
Distribution
Nationwide within the United States
Location
El Paso, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by CareFusion 213, LLC. Units affected: 707,050 eaches.
Why was this product recalled?
Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 19, 2021. Severity: Critical. Recall number: D-0373-2021.