Device recall
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A
- Recall number
- Z-3078-2026
- 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
- OJK
- Device type
- Eye 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
- DYKS1583A UDI-DI 10198459146640 Lot 24KBP388
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States