Device product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, 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.
Z-0960-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67266
- Status
- Terminated
- Classification
- Class I
- Quantity
- 190,871 each (148, 275 US)
- Official record key
device-enforcement:Z-0960-2014
Official wording
Reason: The tracheal tube can kink during patient use.
Code information: Product Code: 5-14015, Lot numbers: 01B1200107, 01J1200211, 01C1200387, 01H1200157, 01E1300478 and 01K1300343.
Distribution pattern: 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.
Derived failure modes
-
Unknown
The tracheal tube can kink during patient use.