CareFusion 213, LLC recalls BD ChloraPrep Hi-Lite Orange

Recalling company

CareFusion 213, LLC

Product

BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catalog number 930415NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

Reason

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jun 11, 2026

Reported

Jul 8, 2026

Distribution

Distributed Nationwide in the USA

Status

Ongoing

Quantity

7,650 units

Lot / codes

Lot: a) 3194046, Exp. 06/30/2026, 3217036, Exp 07/31/2026, 3279434, Exp 09/30/2026, 3286268, 3304460, Exp 10/31/2026, 3346277, Exp 11/30/2026, 4031686, 4039656, Exp 01/31/2027, 4048949, 4060437, 4067207, Exp 02/28/2027, 4092773, 4094978, 4106623, Exp 03/31/2027, 4120371, 4129596, Exp 04/30/2027, 4144918, Exp 05/31/2027, 4193623 4200771, Exp 06/30/2027, 4227747, 4250845, Exp 08/31/2027, 50872610, 5093809, Exp 03/31/2028, 5121323, Exp 04/30/2028. b) 3331331, Exp 11/30/2026, 4284935, Exp 10/31/2027, 4344682, Exp 11/30/2027, 5015852, Exp 01/31/2028, 5086227, Exp 03/31/2028.

Company location

El Paso, TX

Recall type

Voluntary: Firm initiated

Recall number

D-0647-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0647-2026 in the FDA Enforcement Report. Also see FDA recall press releases.