Device Recall Sarns

  • Modelo / Serial
    Catalog number: 80003-02 and lot number: MH12, MK30, MP06, NA31, NE18, NF23, NM31, NN28, NP19, and PD05.
  • 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 HENDRICKSO || 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
    All Lot Codes
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates,and Vietnam.
  • Descripción del producto
    Sarns TCM, Catalog No. 15747 || The Sarns TCM is indicated for controlling and monitoring patient temperature .
  • Manufacturer
  • Modelo / Serial
    All Lot Codes
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates,and Vietnam.
  • Descripción del producto
    Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 || The Sarns TCM is indicated for controlling and monitoring patient temperature .
  • Manufacturer
  • Modelo / Serial
    Serial numbers 0001 through 2696.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Woldwide, including USA, Canada, and Mexico
  • Descripción del producto
    Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.
  • Manufacturer
  • 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
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