Z-3069-2026 Class II Ongoing
FDA device recall Z-3069-2026 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 BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B
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
DYNJ42828B UDI-DI 10198459425516 Lots 25GBQ173 25HBB240 25JBD028 25LBL133 26ABU673 26CBN583 26EBD855 26FBO892; DYNJ42832B UDI-DI 10198459425530 Lots 25LBE548 26BBG040 26CBH272 26EBC041 26FBD497