FDA-Device2026-02-18Class II

Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

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

141,971

Manufactured in

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

Products

Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1312-2026

Original summary

Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit 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 lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿ Distribution: Distribution US nationwide and Canada. Affected quantity: 141,971

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