FDA recall D-0622-2026

CareFusion 213, LLC · Class II · drug

Product

BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.

Reason for recall

Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Distribution

Nationwide inthe USA, as well as other foreign distribution.

Key facts

Status
Ongoing
Initiation date
2026-05-28
Report date
2026-07-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0622-2026