Recall Z-3260-2026

Reason for recall

Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.

FDA-determined cause: Packaging process control

Action taken

Consignees were initially notified on about 07/22/2026 via "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter. They were informed that product may exhibit an open or incomplete seal on the packaging of the applicator. Consignees were instructed to quarantine impacted product, discontinue use of the BD ChloraPrep Clear - 1 mL Applicators within the kits, add a warning label to instruct users to discard the impacted component, and notify customers if the kits had been further distributed. Consignees were notified again on about 08/20/2026 with an updated "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter. Consignees were informed that certain lots of the BD ChloraPrep Applicators are contaminated with Aspergillus penicillioides. Instructions included to discard impacted kits containing affected applicators and notify customers if the kits had been further distributed. For those unaffected by the contamination, but are included in the action regarding sterility concerns, they were instructed to quarantine impacted product, discontinue use of the BD ChloraPrep Clear - 1 mL Applicators within the kits, add a warning label to instruct users to discard the impacted component, and notify customers if the kits had been further distributed.