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Recall Observatory FDA recall evidence

Device product

Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.

Z-1334-2026

December 24, 2025

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98284
Status
Ongoing
Classification
Class II
Quantity
8445 kits
Official record key
device-enforcement:Z-1334-2026

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: 1) Kit SKU DM320C, UDI/DI 10653160997504, Lot Number 25EBQ881; 2) Kit SKU DT15780A, UDI/DI 10653160323303, Lot Number 25EBH827; 3) Kit SKU DT16615, UDI/DI 10653160259268, Lot Number 25EBC730; 4) Kit SKU DT19660, UDI/DI 10653160283041, Lot Number 25EBD629; 5) Kit SKU DT19665, UDI/DI 10653160283263, Lot Number 25EBU086; 6) Kit SKU DT21495, UDI/DI 10653160320593, Lot Number 25EMJ081; 7) Kit SKU DT22510A, UDI/DI 10193489499247, Lot Number 25EMJ351; 8) Kit SKU DYNDC3114B, UDI/DI 10198459078880, Lot Number 25EBI085; 9) Kit SKU DYNDC3351, UDI/DI 10195327475482, Lot Number 25EBM451.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    open seal