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Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB

Class II
Recalling firm
Medline Industries, LP
Reason for recall
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Affected products (lot / model / serial)
CDS983348AA UDI-DI 10195327385088 Lots 24IBK346 24JBK539; CDS983348AB UDI-DI 10198459136986 Lots 25CBF097 25HBB232 25HBB761 25HBH209 25HBU907 25JBQ176
Units affected
222,653 total
Distribution pattern
US Nationwide distribution.
Firm location
Northfield, IL, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-3068-2026
Recall initiated
July 20, 2026
FDA classification date
August 31, 2026
FDA report date
September 9, 2026
FDA event ID
99561
Last updated on HTM Vibe
September 23, 2026
View on openFDA