Carefusion 213, Llc: Bd Chloraprep Hi-lite Orange, (2% W/v Chlorhexidine Gluconate (chg) And 70% V/v Isopropyl Alcohol) Packaged As A) 100 X

Recall Summary BD ChloraPrep Hi-Lite Orange skin antiseptic applicators (sold in boxes of 100 or 250) are being recalled because they were not sterilized before being distributed to customers. The products were intended to be sterilized by the manufacturer before sale but were shipped without completing this step. The recall affects applicators distributed nationwide across all U.S. states.

Recalling firm

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

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-06-11

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Distributed Nationwide in the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/51172479-0f9f-4244-9fbc-870746707ed8