Device recall
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B
- Recall number
- Z-3074-2026
- 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
- OJU
- Device type
- Skin Prep Tray
- 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
- DYKS2018 UDI-DI 10198459188480 Lot 25GMI043 DYKS1584A UDI-DI 10198459146633 Lots 24JBA740 25ABF244 DYKS1216I UDI-DI 10198459362668 Lots 25GBP888 25JBD789 26ABL474 26CBF334 26DBD640 26EBB855 26FBC632 DYKM1398B UDI-DI 10198459413827 Lots 25HBI183 25JBK222 25KBA990 25LBJ990 26BBI525 26CBJ249 26EBQ630 26FMF189
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States