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Parker Quality & Compliance

PQC Reg Watch

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Device recall

Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B

FDA recall source

Recall number
Z-3069-2026
Event id
99561
Status
Ongoing
FDA classification
Class II
Recalling firm
Medline Industries, LP
Report date
Sep 9, 2026
Posted
Aug 31, 2026
Initiated
Jul 20, 2026
Center classification date
Aug 31, 2026
Product code
KDD
Device type
Kit, Surgical Instrument, Disposable
Reason
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.
Root cause
Nonconforming Material/Component
Quantity
222,653 total
Code info
DYNJ42828B UDI-DI 10198459425516 Lots 25GBQ173 25HBB240 25JBD028 25LBL133 26ABU673 26CBN583 26EBD855 26FBO892; DYNJ42832B UDI-DI 10198459425530 Lots 25LBE548 26BBG040 26CBH272 26EBC041 26FBD497
Distribution
US Nationwide distribution.
Voluntary or mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States