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Recall Observatory FDA recall evidence

Device product

ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, 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.

Z-0950-2014

January 06, 2014

Class I

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-0950-2014

Official wording

Reason: The tracheal tube can kink during patient use.

Code information: Product Code: 5-13012, Lot numbers: 01A1000055, 01B1000254, 01G1000275, 01J1000399, 01M1000285, 01A1100083, 01A1100448, 01E1100345, 01G1100116, 01B1100212, 01D1100297, 01C1200082, 01F1200369, 01E1200460, 01F1100482, 01F1200401, 01F1300054, 01H1200296, 01H1100157, 01E1300295 and 01F1300176.

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

    reason.no_named_rule · v1.0.0

    The tracheal tube can kink during patient use.