FDA-Device2014-03-05Class I
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Teleflex Medical
Hazard
The tracheal tube can kink during patient use.
Sold states
Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Barbados, Belgium, South Korea, Thailand, New Zealand, Netherlands.
Affected count
190,871 each (148, 275 US)
Manufactured in
2917 Weck Dr., Research Triangle Park, NC, United States
Products
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0963-2014Don't want to check this manually?
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