WhichRecall
Class IIReported 2026-02-18

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

Recalled by Medline Industries, LP

Reason for Recall

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

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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.

Recall Number
Z-1312-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-12-24
Reported
2026-02-18
Distribution
Distribution US nationwide and Canada.
Code Info
Kit lot 48625040001 UDI (ea) 10080196033317 UDI (case) 40080196033318¿
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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