FDA-Device2023-07-05Class I

Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530

TELEFLEX LLC
Hazard

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Sold states
US Nationwide distribution including Puerto Rico.
Affected count
32553 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1855-2023

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