Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A
Summary
The FDA issued a Class II for Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLO 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-3072-2026
Action Date
2026-09-09
Status
Ongoing
Category
device
Product Description
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A
Lot/Code Info: DYNDH1487A UDI-DI 10193489484311 Lots 25AMD225 25BMA495 25GMD834 25HMJ685 26AMD781 26DMI370 26FMG952 26FMJ739
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-3072-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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