Terumo perfusion

Serial numbers 10031, 10033, 10137, 10138, 10614, 10663, 10730, 11131, 11281, 11283, 11361, 11548, 11630, 11751, 12110, 12604, 12686, 12938, 13129, 13719, 13826, 13830, 14712, 15090, 15277, 15278, 15279, 15280, 15284, 15285, 15304, 16003, 16087, 16190, 17099, 17345, 17432 and 17437 through 18122 may be affected by the problem. None have been corrected.

Cardiovascular Devices

2

No

Worldwide: USA and Bangladesh, Belgium, Bolivia, Canada, Chile, Colombia, Costa Rica, Egypt, Equador, Hong Kong, India, Indonesia, Japan, Latin America, Malaysia, Nicaragua, Philippines, Saudi Arabia, Taipe, Taiwan, United Arab Emirates, Uruguay, and Viet Nam.

Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the United States).

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.

Cardiovascular Devices

2

No

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.

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.

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.

Cardiovascular Devices

2

No

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.

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.

Serial numbers 5305, 5377 and 5379.

Cardiovascular Devices

2

No

Worldwide Distribution, USA and Australia, Belgium, Canada, China, Dominican Republic, Egypt, Germany, India, Indonesia, Japan, Malaysia, Mexico, Pakistan, Republic of China, Singapore, South Africa, South Korea, Thailand and United Arab Emirates.

Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280.