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Medline Industries, LP: Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B

Medical DevicesSource: FDA (device) · Date: 2026-02-18

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B
Reason / hazard
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
Classification
Class II
Status
Ongoing
Distribution / sold at
Distribution US nationwide and Canada.
Recall initiated
2025-12-24
Code info
Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318
Product quantity
130
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98285
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