FDA Medical Device Recalls (openFDA)
Medline Industries, LP: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F
- Recall number
- Z-3076-2026
- Recalling firm
- Medline Industries, LP
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F
- Status
- Open, Classified
- Initiated
- 2026-07-20
- Posted
- 2026-08-31
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 222,653 total
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- CDS981762B UDI-DI 10193489306767 Lots 24JBE456 24JBN932 24KBJ154 25ABK513 25CBL684 25HBK086 25IBM188 25KBL720 25LBF812 25LBU497 26ABM665 26CBH544 26CBT272 26FBK806 DYKA1054F UDI-DI 10193489312607 Lots 24ILA823 24JLA285 24LLA226 24LLB033 25BLA842 25ELA624 25GLA270 25HLB055 25KLA019 25KLA187 26BLA150 26CLA717 26DLA410 26ELA772 26FLA756
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MLS
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28