Device Recall Terumo Perfusion System

  • Model / Serial
    Serial Numbers: 2264, 2281, 3077 through 3082, 3084 through 3088, 3092, 3094 through 3110, 3112 through 3115, 3117, 1932x, 1939x through 1943x, 1950x , 1951x, 1954x, 1973x, 1979x, 1980x, 1982x, 1990x, 1994x, 2000x, 2009x, 2014x through 2064x, 2066x through 2163x, 2194x through 2222x, 2225x through 2232x, 2280x, 2282x, 2283x, 2290x, 2294x, 2295x, 2298x through 2301x, 2303x, 2305x, 2306x, 2309x through 2311x, 2313x through 2315x, 2318x, 2319x, 2322x through 2324x, 2330x through 2332x, 2334x through 2347x, 2350x through 2467x, 2469x through 2471x, 2473x t hrough 2503x, 2505x, 2507x through 2529x, 2533x, 2536x, 2539x through 2541x, 2543x through 2551x, 2553x through 2572x, 2574x through 2583x, 2585x through 2609x and 2611x through 2624x.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including USA and countries of Australia, Belgium, Bolivia, Canada, Chile, Ecuador, Egypt, Honduras, Hong Kong, India, Indonesia, Japan, Jordan, Latin America, Malaysia, Panama, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Taiwan, Thailand, United Arab Emirates, Venezuela and Vietnam.
  • Product Description
    Terumo Sarns Level Sensor II (red) (Part # 195274) alarm level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195274. Level sensors are distributed as a finished device, as part of a kit, with a perfusion system 8000 safety monitor or with an Advanced Perfusion System 1 base. || Level sensors are attached to the color coded connectors on the module and then to a hard-shell reservoir. Level detection is used to monitor blood levels in hard-shell reservoirs.
  • Manufacturer
  • 1 Event

Manufacturer

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

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    Hand crank serial numbers 1285 through 1306.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
  • Product Description
    Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405.
  • Manufacturer
  • Model / Serial
    Hand crank serial numbers 1197 through 1214.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
  • Product Description
    Terumo Perfusion System 8000 Base, 5 pump, 220/240v; Model 8000; Catalog No. 16406.
  • Manufacturer
  • Model / Serial
    Hand crank serial numbers 1621 and 1622.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
  • Product Description
    Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410.
  • Manufacturer
  • Model / Serial
    Hand crank serial numbers 1240 through 1247.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
  • Product Description
    Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400.
  • Manufacturer
  • Model / Serial
    Hand crank serial numbers 1963 through 1986.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Belgium, Hong Kong, Japan, Taiwan and United Arab Emirates.
  • Product Description
    Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401.
  • Manufacturer
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