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
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.
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.
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.