Devices

Device Recall Sarns Modular Perfusion System 8000

  • Model / Serial
    Catalog Number 16413; Lot numbers/serial numbers: 1, 2, 3, 246546, 249510, 249511, 249647, 254871, 258279, 263615, 270671, 273712, 274258, 278324, 280640,285001, 290027, 294434, 295965, 301085, 305999, 308323, 316251, 320749, 325181, 326988, 329131, 332078, 332292, 333714, 336835, 337478, 340618, 343974, 348433, 355116, 355594, 358380, 362038, 363388, 367158, 375588, 379930, 381111, 385518, 389149, 392758, 393294, 400090, 400091, 401120 401121, 401127, 401832, 401885, 402285, 402404, 403219 403611, 403717, 404052, 404360, 404929, 405141, 405324, 405558, 405569, 405719, 405855, 406498, 406716, 406781 407341, 407342, 407501, 407639, 407793, 408201, 408359 408600, 409098, 409104, 409291, 409302, 409570, 409755, 410056, 411301, 411699, 412209, 413388, 413575, 413992, 414974, 415022, 415379, 415605, 415844, 416787, 418180 418289, 418482, 418915, 419276, 419555, 419935, 420558 420782, 420850, 421705, 421939, 421941, 422214, 422498 422990, 423664, 425424, 428898, 435660, 439119, 441511 443513, 447675, 448720, 453531, 457904, 461150, 463168 466017, 467449, 469356, 478255, 479117, 483184, 483633, 487810, 91429006, 93323004, 93355004, 93355005 94025004, 94095004, 94095005, 94116005, 94129005, 94129006, 94143005, 94143006, 94186005, 94186006, 94200005, 94200006, 94207006, 94221006, 94256006, 94283006, 94290006, 94297006, 94304006, 94322006, 94339006, 95009006, 95048006, 95061006, 95072006, 95093006, 95101006, 95108006, 95114006, 95124006, 95179006, 95194006, 95219006, 95265006, 95279006, 95300006, 95310006, 95339006, 95363006, 96036006, 96086006, 96102006, 96113007, 96143008, 96162008 96187008, 96193008, 96200008, 96236008, 96250008, 96262008, 96277008, 96295008, 96316008, 96331008, 96338008, 96348008, 96353008, 97006008, 97007008, 97015008, 97017008, 97073008, 97122008, 97133008, 97139008, 97161008, 97168008, 97175008, 97223008, 97238008, 97252008, 97279008, 97286008, 97300008, and W417301.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AL , AR, AZ , CA, CO , CT, DC, DE , FL, GA, HI, IA , ID , IL, IN , KS, KY , LA, MA , MD, MI, MN , MO, MS , MT, NC , ND, NE, NH, NJ, NM , NY, OH , OR, PA , RI, SC , TN, TX , VA, WA , WI, WV, WY, and Puerto Rico and the countries of PERU, Philippines, REPUBLICA, SANTIAGO, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tujunga, United Arab Emirates, Uruguay, Venezuela, Vietnam, Wooddale, and Yemen.
  • Product Description
    Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pressure Board, Cardioplegia Monitor (service part only) || The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
  • 1 Event

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA

9 devices with a similar name

Learn more about the data here

Device Recall Sarns Modular Perfusion System 8000
  • Model / Serial
    Catalog Number 16414; Lot/serial numbers: PT001*, 1001-1064, 1070-1146, 1148-1220,1222-1227,2000-2039,2045-2059,2061- 2064,2100-2157,2159-2203,2205-2335,2337-2399, 2401-2408,3000-3014,3016-3070,3072-3110,3112-3385, 3387-3558, and 3560-3840.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AL , AR, AZ , CA, CO , CT, DC, DE , FL, GA, HI, IA , ID , IL, IN , KS, KY , LA, MA , MD, MI, MN , MO, MS , MT, NC , ND, NE, NH, NJ, NM , NY, OH , OR, PA , RI, SC , TN, TX , VA, WA , WI, WV, WY, and Puerto Rico and the countries of PERU, Philippines, REPUBLICA, SANTIAGO, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tujunga, United Arab Emirates, Uruguay, Venezuela, Vietnam, Wooddale, and Yemen.
  • Product Description
    Sarns Modular Perfusion System 8000 Catalog number 16414 Cardioplegia Monitor || The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
Device Recall Sarns Modular Perfusion System 8000
  • Model / Serial
    Catalog Number 16413; Lot numbers/serial numbers: PT003*, 1001-1079, 1085-1270, 1276,2000-2013,2015-2028, 2030-2109, 2111-2295, 2297-2396, 2398-2433, 2435-2439, 3000-3020, 3022-3052, 3054-3065, 3067-3104, 3106-3197, 3199-3211, 3213-3593, 3595-3634, 3636-3827, and 3829-3908.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AL , AR, AZ , CA, CO , CT, DC, DE , FL, GA, HI, IA , ID , IL, IN , KS, KY , LA, MA , MD, MI, MN , MO, MS , MT, NC , ND, NE, NH, NJ, NM , NY, OH , OR, PA , RI, SC , TN, TX , VA, WA , WI, WV, WY, and Puerto Rico and the countries of PERU, Philippines, REPUBLICA, SANTIAGO, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tujunga, United Arab Emirates, Uruguay, Venezuela, Vietnam, Wooddale, and Yemen.
  • Product Description
    Sarns Modular Perfusion System 8000 Catalog number 16413 Arterial Monitor || The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
Device Recall Sarns Modular Perfusion System 8000
  • Model / Serial
    Catalog Number 16413; Lot numbers/serial numbers: 1, 2, 3, 246553, 249652, 253943, 256867, 258565, 263614, 269567, 276866, 279012, 281191, 288150, 290070, 296227, 298374, 303142, 308343, 309896, 320618, 323004, 325187, 327295, 329342, 330149, 331788, 333055, 335139, 337482, 341259, 343978, 349845, 352311, 355122, 358382, 358383, 360213, 367161, 370516, 376523, 378092, 381115, 383781, 389150, 392116, 395215, 400085, 400086, 400833, 401042, 401570, 401675, 402124, 402264, 403141, 403142, 403545, 403712, 403719, 404180, 404359, 405057, 405333, 405712, 405859, 406219, 406366, 406512, 406717, 407049, 407241, 407338, 407620, 407637, 407813, 407902, 408362, 408526, 408666, 409214, 409283, 409297, 409422, 409571, 410057, 410250, 410397, 411130, 411208, 411295, 411563, 412058, 412213, 412890, 413161, 413182, 414317, 414363, 414815, 415034, 415250, 415670, 416854, 417128, 417433, 417435, 417561, 418217, 418779, 418911, 419146, 419556, 420313, 420687, 421632, 421834, 422083, 422739, 423663, 424267, 426877, 429622, 430398, 438156, 439123, 444234, 445779, 448180, 452751, 455760, 458517, 461157, 463964, 467455, 468739, 479124, 483205, 483635, 487380, 9434006, 93326004, 94059004, 94115004, 94123004, 94123005, 94130005, 94143005, 94143006, 4158005, 94175005, 94179005, 94179006, 94186005, 94186006, 94200005, 4200006, 94206005, 94206006, 94234006, 94249006, 94284006, 94297006, 94304006, 94311006, 94318006, 95006005, 95048006, 95059006, 95067006, 95086006, 95094006, 95108006, 95114006, 95122006, 95171006, 95174006, 95215006, 95223006, 95234006, 95244006, 95265006, 95282006, 95305006, 95312006, 95345006, 95356006, 96043006, 96091 006, 961 03006, 961 08006, 96143008, 96158008, 96162008, 96200008, 96228008, 96236008, 96241008, 96253008, 96277008, 96295008, 96313008, 96344008, 96348008, 96353008, 97004008, 97006008, 97007008, 97052008, 97066008, 97087008, 97113008, 97120008, 97132008, 97141008, 97156008, 97157008, 97161008, 97199008, 97223008, 97230008, 97238008, 97261008, 97279008, 97302008, and 97308008.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AL , AR, AZ , CA, CO , CT, DC, DE , FL, GA, HI, IA , ID , IL, IN , KS, KY , LA, MA , MD, MI, MN , MO, MS , MT, NC , ND, NE, NH, NJ, NM , NY, OH , OR, PA , RI, SC , TN, TX , VA, WA , WI, WV, WY, and Puerto Rico and the countries of PERU, Philippines, REPUBLICA, SANTIAGO, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Tujunga, United Arab Emirates, Uruguay, Venezuela, Vietnam, Wooddale, and Yemen.
  • Product Description
    Sarns Modular Perfusion System 8000 Catalog number 149112 or 78-8067-4840-2 Temperature-Pressure Board, Arterial Monitor (service part only) || The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
Device Recall Sarns Modular Perfusion System 8000
  • Model / Serial
    Catalog Number 16400 and serial number 1001-1333
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, GERMANY, Guatemala, HOLLAND, Honduras, Hong Kong, India, INDIA, Indonesia, Israel, ITALY, Jordan, KOREA, Kuwait, Lebanon, LEICESTERSHIRE, Malaysia, Mexico, NETHERLANDS, New Zealand, Nicaragua, NORWAY, Pakistan, Panama, PERU, Philippines, Russia, Saudi Arabia, SINGAPORE , SOUTH AFRICA, South Korea, SPAIN, Sri Lanka, SWEDEN, SWITZERLAND, Taiwan, THAILAND, Turkey, UNITED ARAB EMIRATES (UAE), Uruguay, Venezuela, Vietnam, WEST GERMANY and Yemen.
  • Product Description
    Sarns Modular Perfusion System 8000 base, 4 pump 115V. || The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
Device Recall Sarns Modular Perfusion System 8000
  • Model / Serial
    Catalog Number 16401 and serial number PT003, 1001-3001
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, GERMANY, Guatemala, HOLLAND, Honduras, Hong Kong, India, INDIA, Indonesia, Israel, ITALY, Jordan, KOREA, Kuwait, Lebanon, LEICESTERSHIRE, Malaysia, Mexico, NETHERLANDS, New Zealand, Nicaragua, NORWAY, Pakistan, Panama, PERU, Philippines, Russia, Saudi Arabia, SINGAPORE , SOUTH AFRICA, South Korea, SPAIN, Sri Lanka, SWEDEN, SWITZERLAND, Taiwan, THAILAND, Turkey, UNITED ARAB EMIRATES (UAE), Uruguay, Venezuela, Vietnam, WEST GERMANY and Yemen.
  • Product Description
    Sarns Modular Perfusion System 8000 base, 5 pump 115V. || The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation
4 more