FDA 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.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2021-04-20

Report date

2021-05-19

Termination date

2023-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0373-2021