Device Recall Terumo

  • Modèle / numéro de série
    Product Code: SV-S25FL35 Lot Numbers 1508023, 1509011 and 1510004.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    California
  • Description du dispositif
    Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Terumo Medical Corp, 2101 Cottontail Lane, Somerset NJ 08873-1277
  • Société-mère du fabricant (2017)
  • Source
    USFDA

138 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Part Number 804115 lot 0520497, 0528973, 0569610, 0606841.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Part Number 804117 Lot 0520484, 0528974, 0555870, 0565140, 0569078, 0584967, 0613859, 0618949, 0621707, 0626263, 0633299.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Part Number 804159 lot 0520498, 0528975, 0567050, 0582503, 0617088, 0624866.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of BELGIUM, BRAZIL, DOMINICAN REPUBLIC, UNITED ARAB EMIRATES (UAE), SINGAPORE, MALAYSIA, AND SOUTH AFRICA.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lot numbers: 0011-0610,1001-1034,1037-1049,1100,1103-1445, and 1447-1449.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Catalog number 816571 (Serial Number 5315)
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: CA, KY, MO, NE, PA and TX and the countries of Canada and Europe.
  • Description du dispositif
    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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