Device Recall Sarns

  • Modelo / Serial
    Catalog number: 80004-03 and lot number: NP20
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) including the states of: AL, AR , AZ , CA, CT , FL, IA , IL, IN , KS , LA , MI , NM, MO , NC, NE , NJ , NV, NY , OH, OK , PA, RI , SC , TN, TX, WA , WI, WV and the countries of: BELGIUM, BRAZIL, Byelorussian SSR, CAMBODIA , Dominican Republic, Honduras, Japan, Malaysia, Mexico, Nicaragua, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, UNITED ARAB EMIRATES (UAE), and Vietnam.
  • Descripción del producto
    CPB CATHETER KIT-DR VANTRIGHT || Product Usage: || The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

121 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Catalog number 6090, Serial Numbers 0 - 10186
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA, and the countries of Colombia, Argentina, Lebanon, Belgium, Chile, India, Sri Lanka, Jordan, Egypt, Mexico, Brazil, Taiwan, Honduras, Canada, Germany, Singapore, Republic of Georgia, Hong Kong, Japan, UAE, Philippines, Thailand and South Africa.
  • Descripción del producto
    Terumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated for use in splitting the sternum during thoracic surgery.
  • Manufacturer
  • Modelo / Serial
    catalog number: 5779; lot numbers: 0545579, 0548150, 0554137,0558396, 0562512, 0569935, 0576823, 0584962, 0589209, 0595115, 0601515, 0606478, 0612440, 0618280, 0622453, 0626218, 0635379, 0639446, and 0646536.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of: CANADA, CHILE, India, Japan, Singapore, AUSTRALIA, Malaysia, BELGIUM, BELGIUM, BRAZIL, CHILE, BRAZIL, BRAZIL, and Philippines.
  • Descripción del producto
    Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 12" (31 em) long. || Product Usage: CTS Usage: || The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.
  • Manufacturer
  • Modelo / Serial
    Catalog Number: 5767 and lot numbers: 0545582, 0548139, 0548619, 0549398, 0553274, 0555865, 0558398, 0559101, 0564329, 0569936, 0572248, 0577873, 0583200, 0589210, 0592730, 0597079, 0601909, 0607221, 0613013, 0618448, 0621281, 0624903, 0626217, 0630092, 0633295, 0636279, 0641286, 0643913, 0648095, 581714C, and 628998C.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of: CANADA, CHILE, India, Japan, Singapore, AUSTRALIA, Malaysia, BELGIUM, BELGIUM, BRAZIL, CHILE, BRAZIL, BRAZIL, and Philippines.
  • Descripción del producto
    Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long. || Product Usage: CTS Usage: || The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.
  • Manufacturer
  • Modelo / Serial
    Catalog number 5767X and lot numbers: 0602378, 0619845, 0633666, and 0641873.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of: CANADA, CHILE, India, Japan, Singapore, AUSTRALIA, Malaysia, BELGIUM, BELGIUM, BRAZIL, CHILE, BRAZIL, BRAZIL, and Philippines.
  • Descripción del producto
    Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long, with X Coating surface coating. || Product Usage: CTS Usage: || The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.
  • Manufacturer
  • Modelo / Serial
    catalog number: 5761 and lot numbers: 0545183, 0545583, 0548140, 0548618, 0549399, 0553276, 0555220, 0555866, 0556607, 0559102, 0562330, 0567184, 0568703, 0571184, 0576564, 0579082, 0582492, 0587313, 0591057, 0596897, 0601695, 0603419, 0610242, 0614233, 0618452, 0620914, 0622327, 0626216, 0630792, 0633214, 0633296, 0637311, 0640508, 0643258, 0647967, and 628995C.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of: CANADA, CHILE, India, Japan, Singapore, AUSTRALIA, Malaysia, BELGIUM, BELGIUM, BRAZIL, CHILE, BRAZIL, BRAZIL, and Philippines.
  • Descripción del producto
    Sarns Soft-Flow Aortic Cannula; Aortic cannula, 7.0 mm (21 Fr) OD with 3/8" connector, 14" (36 em) long. || Product Usage: CTS Usage: || The Sarns-Aortic Cannula is indicated for use In perfusion of the ascending aorta during cardiopulmonary bypass surgery. The X-Coating is intended to reduce the adhesion of platelets to the blood contacting surfaces of the device during cardiopulmonary bypass procedures.
  • Manufacturer
116 más