Z-3075-2026 Class II Ongoing
FDA device recall Z-3075-2026 was initiated by Medline Industries, LP on July 20, 2026 and is designated Class II. 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. U… The recall status is ongoing. Affected quantity: 222,653 total.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2026
- Initiation Date
- July 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 222,653 total
Product Description
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.
Distribution Pattern
US Nationwide distribution.
Code Information
DYKA1384B UDI-DI 10198459415753 Lot 25GBS617 DYKA1384C UDI-DI 10198459485206 Lot 25IBF898 DYKS1206D UDI-DI 10198459414794 Lots 25HBI181 25JBJ452 25LBJ223 26ABT372 26CBF527 26EBH733