Device Recall Terumo

  • Modelo / Serial
    Convenience Kit Identifier Code/Kit Lot Numbers: 65077 FA17 62266-01 EP13 62266-01 FA31 63819-01 FC07 64034 FA03 64033 FD07 70131 FA03 70131 FA10 63607 FA31 63607 FD07 64091 FC07 64338 EP13 64338 FC07 70964 EP20 70964 FD07 70014-02 EP13 70014-02 FA03 70014-02 FC07 70014-02 FC07T 70014-02 FD07 70226-01 FD07 64987 FA24 64987 FD14 62933-01 FD14 62984-01 FA24 63004-01 FA03 63004-01 FA24 63361-01 EP27 63118 EP13 63118-01 FA24 63118-01 FC28 63118-01 FD14
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AZ, CA, KY, IL, LA, MD, WA , WI
  • Descripción del producto
    Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump || The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits) as follows: || Convenience Kit Identifier Code/Kit Lot Numbers: || 65077 FA17 || 62266-01 EP13 || 62266-01 FA31 || 63819-01 FC07 || 64034 FA03 || 64033 FD07 || 70131 FA03 || 70131 FA10 || 63607 FA31 || 63607 FD07 || 64091 FC07 || 64338 EP13 || 64338 FC07 || 70964 EP20 || 70964 FD07 || 70014-02 EP13 || 70014-02 FA03 || 70014-02 FC07 || 70014-02 FC07T || 70014-02 FD07 || 70226-01 FD07 || 64987 FA24 || 64987 FD14 || 62933-01 FD14 || 62984-01 FA24 || 63004-01 FA03 || 63004-01 FA24 || 63361-01 EP27 || 63118 EP13 || 63118-01 FA24 || 63118-01 FC28 || 63118-01 FD14
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Terumo Cardiovascular Systems Corp, 6200 Jackson Rd, Ann Arbor MI 48103-9586
  • Source
    USFDA

138 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Part Number 804115 lot 0520497, 0528973, 0569610, 0606841.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.
  • Descripción del producto
    804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long || A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
  • Manufacturer
  • Modelo / Serial
    Part Number 804117 Lot 0520484, 0528974, 0555870, 0565140, 0569078, 0584967, 0613859, 0618949, 0621707, 0626263, 0633299.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.
  • Descripción del producto
    804117, Terumo Coronary Ostia cannula, 12 Fr, 10 (25 cm) long || A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment
  • Manufacturer
  • Modelo / Serial
    Part Number 804159 lot 0520498, 0528975, 0567050, 0582503, 0617088, 0624866.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.
  • Descripción del producto
    804159, Terumo Coronary Ostia cannula, 14 Fr, 10 (25 cm) long || A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
  • Manufacturer
  • Modelo / Serial
    Lot numbers: 0011-0610,1001-1034,1037-1049,1100,1103-1445, and 1447-1449.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution--USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, Puerto Rico and the countries of INDIA, CANADA, CHILE, HONG KONG, EGYPT, PAKISTAN, KUWAIT, SAUDI ARABIA, JORDAN, UNITED ARAB EMIRATES, SOUTH AFRICA, SOUTH KOREA, PHILIPPINES, JAPAN, PHILIPPINES, SINGAPORE, AUSTRALIA, MALAYSIA, TAIWAN, RUSSIA, TURKEY, BELGIUM, GERMANY, COLUMBIA, COSTA RICA, ARGENTINA, HONDURAS, COLUMBIA, DOMINICAN REPUBLIC, GUATEMALA, MEXICO, VIETNAM, and THAILAND.
  • Descripción del producto
    Terumo Advanced Perfusion System 1 Base, 100/120V, Catalog 801763, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. Indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
  • Manufacturer
  • Modelo / Serial
    Catalog number 816571 (Serial Number 5315)
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.
  • Descripción del producto
    Terumo Advanced Perfusion System 1- 6" Roller Pump for Terumo System 1 (gray) || Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
  • Manufacturer
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