Recall Z-3074-2026
- Recall number
- Z-3074-2026
- Event number
- 99561
- Firm
- Medline Industries, LP
- Firm FEI
- 1417592
- Product code
- OJU
- Status
- Open, Classified
- Initiated
- 2026-07-20
- Posted
- 2026-08-31
- Root cause
- Nonconforming Material/Component
- 510(k) numbers
- K781797
Product#
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
Reason for Recall#
Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.