Device Recall TruChoice and 3T Medical Systems Adjustable Vent Valve

  • Modelo / Serial
    Lot # 2011-06-18 thru 2014-06-01
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Michigan, Tennessee, New York, and California and the countries of Chile and Korea
  • Descripción del producto
    Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035NS QUANTITY: 100, DESCRIPTION: NONADJUSTABLE VENT VALVE, NON-STERILE; AND and 3-T Medical Systems, Catalog #035NS, Non-Adjustable One Way Vent Valve, Quantity: 100, NON-STERILE || The TrueChoice and 3-T Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Alliant Enterprises LLC, 8850 M 89, Richland MI 49083-8558
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

Dispositivo con un nombre similar

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  • Modelo / Serial
    All Lot Numbers thru 2013-11-23
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including Michigan, Tennessee, New York, and California and the countries of Chile and Korea
  • Descripción del producto
    Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030NS QUANTITY: 100 DESCRIPTION: ADJUSTABLE VENT VALVE, NON-STERILE; and 3T Medical Systems Catalog# 030NS Adjustable One Way Vent Valve, Quantity: 100, NON-STERILE || The TruChoice and 3-T Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart.
  • Manufacturer