FDA recall D-0243-2026

CareFusion 213, LLC · Class II · drug

Product

BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29

Reason for recall

Lack of Assurance of Sterlity

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2025-12-17
Report date
2026-01-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0243-2026