Recall Z-3071-2026

Medline Industries, LP · initiated July 20, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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

Codes / lots: CDS860014Q UDI-DI 10198459629822 Lots 26ABR359 26BBP789 26CBL940 26DBK987 26FBK255 26FBK816 DYKM1000B UDI-DI 10889942508143 Lots 24KMD782 24LMH404 25AMD765 25BMD744 CDS860014P UDI-DI 10888277797819 Lots 24IBA155 24JBY045 24LBM014 25HBR509 25JBX951 DYNDV2684 UDI-DI 10198459185465 Lot 24LBP243

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.

FDA-determined cause: Nonconforming Material/Component

Action taken

Firm began notifying consignees on 7/20/2026 via First-Class Mail and email. Medline Industries LP instructed customers to request stickers to over-label the affected convenience kits with a label indicating to remove the affected component and replace it with product from supply. No kits are to be returned.

Details

Recall number
Z-3071-2026
Initiated
July 20, 2026
Posted by FDA
August 31, 2026
Product code
LRS – I.V. Start Kit
Quantity
222,653 total
Distribution
US Nationwide distribution.
Recalling firm
Medline Industries, LP, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-3067-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3068-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3069-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3070-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3072-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3073-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3074-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3075-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3076-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3077-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3078-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified
Z-3079-2026 Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… 07/20/2026Open, Classified