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Recall Observatory FDA recall evidence

Device product

Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B

Z-1326-2026

December 24, 2025

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98284
Status
Ongoing
Classification
Class II
Quantity
120 kits
Official record key
device-enforcement:Z-1326-2026

Official wording

Reason: Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

Code information: UDI/DI 10193489217070, Lot Number 25EBJ414

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    open seal