Devices

Medtronic Disposable Pressure Display Set

  • Modelo / Serial
    Lot numbers: 2008070788, 2008070792, 2008070793, 2008070955, 2008080357, 2008080359, 2008080385, 2008080426, 2008080441, 2008080525, 2008080545, 2008081109, 2008081195, 2008090080, 2008090244, 2008090980, 2008091122, 2008091123, 2008091125, 2008100001, 2008100531, 2008100583, 2008100605, 2008100607, 2008101323, 2008101324, 2008101325, 2008101368, 2008101375, 2008101379, 2008101380, 2008110008, 2008110173, 2008110287, 2008110301, 2008110530, 2008110531, 2008110612, 2008110720, 2008110876, 2008110877, 2008110878, 2008111157, 2008111209, 2008111210, 2008120149, 2008120150, 2008120478, 2008120848, 2008120849, 2008120850, 2008120851, 2008121107, 2009010121, 2009010122, 2009010603, 2009010604, 2009010605, 2009010953, 2009010954, 2009010955, 2009011280, 2009011281, 2009011282, 2009011283, 2009011284, 2009020119, 2009020581, 2009020841, 2009020842, 2009020843, 2009030102, 2009030327, 2009030328, 2009030329, 2009030330, 2009030626, 2009030955, 2009031171, 2009031172, 2009040538, 2009040539, 2009040540, 2009040541, 2009040834, 2009041092, 2009041093, 2009041094, 2009050183, 2009050527, 2009050528, 2009050529, 2009050867, 2009050868, 2009050975, 2009050976, 2009060054, 2009060381, 2009060382, 2009060383, 2009060633, 2009060640, 2009060641, 2009060642, 2009060696, 2009061139, 2009070210, 2009070487, 2009070488, 2009070912, 2009071231, 2009080403, 2009080404, 2009080405, 2009080406, 2009080407, 2009081128, 2009081129, 2009081130, 2009081131, 2009081851, 2009090137, 2009090589, 2009090590, 2009090591, 2009091085, 2009100116, 2009100118, 2009100443, 2009100444, 2009100445, 2009100446, 2009100882, 2009100974, 2009100975, 2009100976, 2009100977, 2009100978, 2009101597, 2009101598, 2009102220, 2009102221, 2009102222, 2009110186, 2009110859, 2009110861, 2009111388, 2009112071, 2009120316, 2009120317, 2009120788, 2009120789, 2009120790, 2009120791, 2009121304, 2009121305, 2009121306, 2009121701, 2009121704, 2010010236, 2010010237, 2010010238, 2010011329, 2010011330, 2010011525, 2010011526, 2010011527, 2010021286, 2010022073, 2010022074, 2010031328, 2010031329, 2010031330, 2010031331, 2010031332, 2010031333, 2010032084, 2010032085, 2010032086, 2010032087, 2010032816, 2010032817, 2010032818, 2010032819, 2010032820, 2010033477, 2010033478, 2010033479, 2010040563, 2010040564, 2010040947, 2010040948, 2010040949, 2010041433, 2010050370, 2010050371, 2010050726, 2010050963, 2010051276, 2010051363, 2010060108, 2010060280, 2010060558, 2010060689, 2010061703, 2010061759, 2010062023, 2010062558, 2010062870, 2010062871, 2010070115, 2010071372, 2010071373, 2010071375, 2010071377, 2010071570, 2010071868, 2010080229, 2010080231, 2010080810, 2010080811, 2010080812, 2010081270, 2010081424, 2010081602, 2010081604, 2010081606, 2010082011, 2010082012, 2010082218, 2010082219, 2010082439, 2010090223, 2010090420, 2010090497, 2010090615, 2010090759, 2010090939, 2010090952, 2010091040, 2010091666, 2010091802, 2010092208, 2010092209, 2010092472, 2010092505, 2010100038, 2010100237, 2010100249, 2010100374, 2010100376, 2010100681, 2010101291, 2010101293, 2010101374, 2010101385, 2010101493, 2010101961, 2010101974, 2010110030, 2010110033, 2010110974, 2010120220, 2010120424, 2010120605, 2010120606, 2010121586, 2010121587, 2010122170, 2010122208, 2011010069, 2011010367, 2011010368, 2011011063, 2011011067, 2011011311, 2011011454, 2011011931, 2011020018, 2011020019, 2011020217, 2011020218, 2011020581, 2011020583, 2011020585, 2011020955, 2011020956, 2011021012, 2011021014, 2011021155, 2011021156, 2011021157, 2011021668, 2011021669, 2011021991, 2011021993, 2011022187, 2011022188, 2011030015, 2011030089, 2011030090, 2011030095, 2011030155, 2011030156, 2011030311, 2011030312, 2011031091, 2011031094, 2011031450, 2011031610, 2011031611, 2011031685, 2011032335, 2011032336, 2011040004, 2011040025, 2011040026, 2011040260, 2011040261, 2011040365, 2011040366, 2011040811, 2011040812, 2011041038, 2011041070, 2011041092, 2011041194, 2011041306, 2011041307, 2011041573, 2011041574, 2011041590, 2011041592, 2011050006, 2011050362, 2011050363, 2011050397, 2011050398, 2011050657, 2011050697, 2011051009, 2011051238, 2011051239, 2011051381, 2011051382, 2011051696, 2011051704, 2011060013, 2011060014, 2011060184, 2011060373, 2011060375, 2011060551, 2011060680, 2011060726, 2011060786, 2011061269, 2011061271, 2011062118, 2011062119, 2011062400, 2011062401, 2011062402, 2011070035, 2011070036, 2011070285, 2011070287, 2011070847, 2011070848, 200806C084, 200806C089, 200808C026, 200808C094, 200808C109, 200811C004, 200811C005, 200811C038, 200812C005, 200903C075, 200905C126, 200908C163, 200908C164, 200910C047, 200910C175, 200910C182, 200910C183, 200911C085, 200912C010, 201001C087, 201002C045, 201002C135, 201005C040, 201006C018, 201007C033, 201008C040, 201009C132, 201009C180, 201009C181, 201011C104, 201011C132, 201011C139, 201012C042, 201101C032, 201102C103, 201103C061, 201104C019, 201104C064, 201104C106, 201105C057.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including Puerto Rico, and Virgin Islands (U.S.) and the countries of: Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Yemen.
  • Descripción del producto
    Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded transducer dome (acrylic) with silicone diaphragm on proximal end. Product utilizes a stopcock on proximal and/or distal end. Distal end of tubing features a male luer port. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. || Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.
  • Manufacturer
    Medtronic Perfusion Systems
  • 1 Event

Fabricante

Medtronic Perfusion Systems
  • Dirección del fabricante
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

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Más información acerca de la data acá

Medtronic Disposable Pressure Display Set
  • Modelo / Serial
    Models 0K57R2, 0K82R15, 0M63R7, 0M68R6, 0N41R14, 0T50R5, 0V67R27, 0X52R3, 0Y35R, 0Y95R30, 0Z30R11, 1D41R16, 1F66R12, 1G59R1, 1J74R4, 1M90R8, 1P09R2, 2031R7, 2C88R8, 2C89R7, 2C90R7, 2C91R5, 2D61R2, 2D64R16, 2H08R3, 2K85R1, 2K87R1, 2K88R1, 2N90R9, 2T28R1, 3B74R2, 3T73R1, 3W29R, 4B42R5, 4C03R, 4D82R3, 4M55R, 4N04R, 4R43R, 5788R4, 5A45R3, 5B51R9, 5B94R, 5C33R2, 5C45R3, 5C92R9, 5D83R2, 5F68R1, 5G28R4, 5H65R, 5J00R2, 5P62R, 5W13R6, 5Z18R, 6G05R, 6J55R1, 6J88R4, 6J95R8, 6N12R, 6Q49R1, 6Q49R1, 6R08R, 6R09R, 6R44R2, 6S66R, 6S75R1, 6V25R, 6Y04R5, 6Y07R6, 6Y59R3, 7A69R4, 7A70R1, 7B56R1, CB0L44R16, CB0M02R5, CB0M79R8, CB1Q18R11, CB1S33R9, CB2D32R5, CB2W45R7, CB2W86R4, CB3K45R9, CB3K91R1, CB3M40R17, CB3Y46R9, CB3Y47R10, CB4800R18, CB4953R16, CB4958R16, CB4B68R8, CB4E78R7, CB4F45R15, CB4K64R6, CB4L83R4, CB4M60R2, CB4S43R9, CB4W10R10, CB4X84R, CB4Y71R14, CB4Z87R6, CB5A30R10, CB5F84R12, CB5J33R6, CB5L15R13, CB5L79R, CB5L90R16, CB5Q71R2, CB5Q74R1, CB5R04R1, CB5R46R5, CB5U81R, CB6A80R6, CB6G02R4, CB6H12R, CB6H45R4, CB6H76R, CB6H77R, CB6H78R, CB6J66R2, CB6J68R3, CB6J75R3, CB6L12R3, CB6L13R, CB6L14R, CB6L60R2, CB6M11R1, CB6Q15R, CB6Q16R1, CB6Q62R, CB6Q78R2, CB6S17R, CB6U12R, CB6U76R1, CB6X94R2, CB6X98R3, CB6Y02R6, CB6Y34R2, CB7C31R, DLP2X17R, HY0F32R17, HY2280R16, HY2U14R2, HY3U59R12, HY4A96R9, HY4V52R4, HY4V82R3, HY5D07R2, HY6B26R2, HY6G55R6, HY6G56R6, HY6H03R5, HY6H03R5, HY6J33R3, HY6J99R, HY6R36R1, HY6R36R1, HY6U70R2, HY6V34R2, HY6Z04R1, M331105H, M331105K, M336902L, M392810D, M392810E, M392811C, M392811D, M392811E, M440115G, M440115H, M440115J, M440115K, M440115L, M440129A, M440130A, M441002E, M443824F, M443825E, M492609A, M499301B, M530710A, M530710C, M530710D, M960208A, M960454B, P390806A, S330115A, SS6X67R1, SS6Z09R1, SSHY6E81R2, TL2H89R7, TL3Y45R1, TL3Z67R4, TL4E64R, TL4E66R10, TL4E66R10, TL5398R21, TL5C09R4, TL5M01R7, TL5R15R4, TL6A91R2, TL6C91R2, TL6D87R2, TL6H39R5, TL6W08R3, TL6X29R4, TL6X36R2, TL6X62R5, TL6Y92R, TL7A15R2.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including Puerto Rico, and Virgin Islands (U.S.) and the countries of: Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Yemen.
  • Descripción del producto
    Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models contain a Pressure Display Set. Sterilized by Ethylene Oxide. Non-pyrogenic. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. || Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.
  • Manufacturer
    Medtronic Perfusion Systems