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Recall Observatory FDA recall evidence

Device product

Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number DYNJAA262A

Z-1182-2025

January 09, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96188
Status
Ongoing
Classification
Class II
Quantity
70 kits
Official record key
device-enforcement:Z-1182-2025

Official wording

Reason: Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.

Code information: 1) DYNJAA254A, UDI-DI 10195327686260 (each) 40195327686261 (case), Lot Number 24KBR956, 24LBA655; 2) DYNJAA262A, UDI-DI 10195327208172 (each) 40195327208173 (case), Lot Number 24LBD397

Distribution pattern: US States: CA, NY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.