Device Recall Terumo Perfusion System

  • Model / Serial
    Serial Numbers: 2036, 3015 through 3086, 3090, 3092 through 3137, 1191x, 2012x through 2035x, 2037x through 2274x, 2276x through 2284x, 2287x through 2290x, 2292x, 2294x through 2297x, 2299x through 2302x, 2304x, 2306x through 2308x, 2311x through 2313x, 2315x through 2326x, 2328x, 2330x through 2337x, 2340x through 2341x, 2343x, 2346x, 2349x through 2352x, 2354x through 2356x, 2358x, 2360x, 2363x through 2365x, 2367x through 2375x, 2379x, 2381x through 2384x, 2391x, 2392x, 2394x, 2395x, 2398, 2399x, 2403x, 2404x, 2405x, 2407x, 2408x, 2410x, 2411x, 2413x, 2415x, 2416x, 2417x, 2419x, 2420x, 2421x, 2423x through 2427x, 2432x, 2435x through 2441x, 2443x through 2466x, 2468x through 2471x, 2473x through 2491x, 2497x through 2500x, 2502x, 2518x, 2521x, 2527x, 2529x through 2533x, 2548x and 2549x.
  • 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 (yellow) (Part # 195215) alert 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 195215. 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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