← FDA ENFORCEMENT
D-0652-2026Class II

CareFusion 213, LLC

Recalling firm
CareFusion 213, LLC
Product type
Drug
Status
Ongoing
Report date
2026-07-08
Distribution
Distributed Nationwide in the USA
Firm state
TX
Product quantity
100 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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

Product description

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.

Code / lot info

Lot: 4190081, Exp 06/30/2027

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IFrutas y Hortalizas del Sur S.A.2026-07-22Class IIGELLERT GLOBAL GROUP2026-07-22Class IICareFusion 213, LLC2026-07-22Class IIChiesi USA, Inc.
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.