Device recall
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A
- Recall number
- Z-3067-2026
- 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
- OFT
- Device type
- Spinal Epidural Anesthesia 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
- UDI-DI 10198459362835 Lots 25IBJ918 25KBN677 25LBU066 26BBD775
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States