Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY AD
Summary
The FDA issued a Class II for Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LAB by Medline Industries, LP. Reason: Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open.
Details
Source
Device Recall
External ID
Z-3076-2026
Action Date
2026-09-09
Status
Ongoing
Category
device
Product Description
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F
Lot/Code Info: 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
Quantity Affected: 222,653 total
Reason for Recall
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-20
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Medline Industries, LP has 577 FDA actions in our database, including 553 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 577 FDA actions in our database, including 553 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3076-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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