Device recall
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
- Recall number
- Z-3068-2026
- Event id
- 99561
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medline Industries, LP
- Report date
- Sep 9, 2026
- Posted
- Aug 31, 2026
- Initiated
- Jul 20, 2026
- Center classification date
- Aug 31, 2026
- Product code
- OEZ
- Device type
- Cardiovascular Procedure Kit
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Quantity
- 222,653 total
- Code info
- CDS983348AA UDI-DI 10195327385088 Lots 24IBK346 24JBK539; CDS983348AB UDI-DI 10198459136986 Lots 25CBF097 25HBB232 25HBB761 25HBH209 25HBU907 25JBQ176
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States