Recall Z-3071-2026
- Recall number
- Z-3071-2026
- Event number
- 99561
- Firm
- Medline Industries, LP
- Firm FEI
- 1417592
- Product code
- LRS
- Status
- Open, Classified
- Initiated
- 2026-07-20
- Posted
- 2026-08-31
- Root cause
- Nonconforming Material/Component
- 510(k) numbers
- K923361, K922533, K925018, K951167, K935684, K925017, K875315, K930196, K852375, K943941, K871731, K863796, K933041, K924811, K963722, K941469, K944041, K001879, K871281, K760876, K820490, K914475, K842898, K844614, K863712, K924538, K942238, K950184, K926031, K050654
Product#
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH CDS860014P ULTRASOUND GUIDED PIV START KI DYNDV2684
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.