Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C
Summary
The FDA issued a Class II for Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAT 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-3075-2026
Action Date
2026-09-09
Status
Ongoing
Category
device
Product Description
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D
Lot/Code Info: DYKA1384B UDI-DI 10198459415753 Lot 25GBS617 DYKA1384C UDI-DI 10198459485206 Lot 25IBF898 DYKS1206D UDI-DI 10198459414794 Lots 25HBI181 25JBJ452 25LBJ223 26ABT372 26CBF527 26EBH733
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-3075-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29