Devices

Medtronic Disposable Pressure Display Set

  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • 1 Event

Fabricant

Medtronic Perfusion Systems
  • Adresse du fabricant
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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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Medtronic Disposable Pressure Display Set
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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