FDA-Device2023-07-05Class I
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570
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
1051810 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1849-2023Don't want to check this manually?
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