FDAFDA recall Z-3075-2026 · Sep 9, 2026
Medline Industries, LP: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KI recall
Recall found
Product
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- DYKA1384B UDI-DI 10198459415753 Lot 25GBS617 DYKA1384C UDI-DI 10198459485206 Lot 25IBF898 DYKS1206D UDI-DI 10198459414794 Lots 25HBI181 25JBJ452 25LBJ223 26ABT372 26CBF527 26EBH733
- Quantity
- 222,653 total
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-20
Source: openFDA enforcement record Z-3075-2026 · search recall number Z-3075-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.