FDA-Device2025-03-19Class I

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

Smiths Medical ASD, Inc.
Hazard

Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

Sold states
Worldwide - US Nationwide distribution.
Manufactured in
6000 Nathan Ln N, Minneapolis, MN, United States
Products
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1289-2025

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