Device Recall Terumo Advance Perfusion System 1

  • Model / Serial
    Lot numbers: 0006-0066, 0100-0322, 1001-1027, 1100-1434, and 1436.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot numbers: 0011-0610,1001-1034,1037-1049,1100,1103-1445, and 1447-1449.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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