FDA-Device2026-02-18Class II

Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B

Medline Industries, LP

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.

Sold states

Distribution US nationwide and Canada.

Affected count

130

Manufactured in

3 Lakes Dr, N/A, Northfield, IL, United States

Products

Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1313-2026

Original summary

Intubation Tray (Adult) containing Suction Catheter Kits SKU DYNJAA245B 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. Kit lots 25IBC172 25HBJ413 UDI (ea) 10198459480317 UDI (case) 40198459480318 Distribution: Distribution US nationwide and Canada. Affected quantity: 130

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