FDA recall D-0652-2026

CareFusion 213, LLC · Class II · drug

Product

BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-34, catalog number 930700NS.

Reason for recall

Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Distribution

Distributed Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2026-06-11
Report date
2026-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0652-2026