PlainRecalls
FDA Devices Critical Class I Terminated

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, 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.

Reported: March 5, 2014 Initiated: January 6, 2014 #Z-0951-2014

Product Description

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, 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.

Reason for Recall

The tracheal tube can kink during patient use.

Details

Recalling Firm
Teleflex Medical
Units Affected
190,871 each (148, 275 US)
Distribution
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.
Location
Research Triangle Park, NC

Frequently Asked Questions

What product was recalled?
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, 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.. Recalled by Teleflex Medical. Units affected: 190,871 each (148, 275 US).
Why was this product recalled?
The tracheal tube can kink during patient use.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 5, 2014. Severity: Critical. Recall number: Z-0951-2014.