Device Recall ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only

  • Model / Serial
    Product Code: 5-13016, Lot numbers: 01A1000317, 01C1000059, 01D1000386, 01D1000112, 01G1000245, 01J1000396, 01M1000284, 01B1100011, 01B1100070, 01C1100114, 01C1100529, 01E1100227, 01C1100606, 01B1100505, 01B1100248, 01H1100103, 01A1200116, 01B1200547, 01B1200422, 01E1100492, 01C1200085, 01C1200385, 01D1100348, 01D1200270, 01D1200087, 01G1100117, 01E1200562, 01G1200079, 01C1300339, 01C1300437, 01D1300076, 01E1300297, 01D1300194 and 01E1300061.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Manufacturer Parent Company (2017)
  • Source
    USFDA