Device Recall Medtronic Trillium Affinity

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers 8870107 and 8851934 (both Model 541T )
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide including the states of IL, CT, OK, OH, MN, FL, NY, KS, MO, LA, PA, IN, CA, MI, KY, SC, NE, and AR.
  • 제품 설명
    Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 제조사 모회사 (2017)
  • 제조사 의견
    “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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution and to the countries of : Australia, Canada, Colombia, Denmark, Germany, Guyana, Israel, Italy, Japan, Netherlands, Norway, Saudi Arabia and United Kingdom.
  • 제품 설명
    Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T || The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    MODEL # / LOT #: 95215/9834158, 95215/9836054, 95215/9840678, 95215/9841550, 95215/9841559, 95215/9845071, 95215/9847467, 95215/9850444, 95215/9855692, 95215/9856192, 95215/9862423, 95215/9864967, 95215/9866563, 95215/9868270, 95215/9871572, 95215/9874613, 95215/9875139, 95215/9882831, 95215/9884748, 95215/9889245, 95215/9891467, 95215/9892254, 95215/9918684, 95216/9842281, 95216/9846078, 95216/9849122, 95216/9851739, 95216/9858463, 95216/9864836, 95216/9870318, 95216/9870329, 95216/9881577, 95216/9885872, 95216/9890513, 95216/9892011, 95216/9895530, 95216/9896568, 95216/9904481, 95216/9905578, 95216/9905755, 95216/9907437, 95216/9911601, 95216/9912191, 95217/9837473, 95217/9837609, 95217/9837669, 95217/9838938, 95217/9839026, 95217/9842333, 95217/9842382, 95217/9842493, 95217/9844162, 95217/9845850, 95217/9846383, 95217/9847644, 95217/9848942, 95217/9849195, 95217/9849848, 95217/9850346, 95217/9851508, 95217/9852863, 95217/9853060, 95217/9854098, 95217/9856703, 95217/9856833, 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TS8388R3/0000675107, TS8388R3/0000675976, TS8388R3/0000677752, TS8388R3/0000677759, TS8388R3/0000683314, TS8388R4/0000679863, TS8388R4/0000680660, TS8388R4/0000680793, TS8388R4/0000681468, TS8388R4/0000682586, TS8388R4/0000685070, TS8388R4/0000685755, TS8388R4/0000685761, TS8388R4/0000687710, TS8388R4/0000688985, TS8388R4/0000689006, TS8388R4/0000690154, TS8388R4/0000691109, TS8388R4/0000692110, TS8388R4/0000692964, TS8388R4/0000694600, TS8388R4/0000694812, TS8388R4/0000696192, TS8388R4/0000698353, TS8388R4/0000699548, TS8388R4/0000700720, TS8388R4/0000701976, TS8388R4/0000703005, TS8388R4/0000704024, TS8388R4/0000705314, TS8388R4/0000707032, TS8388R4/0000708114, TS8388R4/0000709031, TS8388R4/0000710369, TS8388R4/0000711245, TS8388R4/0000712246, TS8388R4/0000713766, TS8388R4/0000714784, TS8388R4/0000716292, TS8388R4/0000718393, TS8388R4/0000720218, TS8388R4/0000721463, TS8388R4/0000724872, TS8388R4/0000727255, TS8390R3/0000667287, TS8390R3/0000671481, TS8390R4/0000693263, TS8390R5/0000702343, TS8390R5/0000725136, TS8397R5/0000725229, TS9412R4/0000680661, TS9412R4/0000686889, TS9412R4/0000700908, TS9412R4/0000700973, TS9412R4/0000704567, TS9412R4/0000715042, TS9412R4/0000721788, TS9416R1/0000666539, TS9416R2/0000676111, TS9416R2/0000689000, TS9416R2/0000696021, TS9416R2/0000709244, TS9416R2/0000711304, TS9416R2/0000721652, TS9416R2/0000723021, TS9420R4/0000724092, TS9422R35/0000673932, TS9422R35/0000677981, TS9422R35/0000683408, TS9422R35/0000688056, TS9422R35/0000690443, TS9422R35/0000698349, TS9422R35/0000699661, TS9422R35/0000702214, TS9422R35/0000709158, TS9422R35/0000713968, TS9422R35/0000726432, TS9422R35/0000727315, TS9423R2/0000666496, TS9423R2/0000686906, TS9423R3/0000674357, TS9423R3/0000682606, TS9423R3/0000693024, TS9423R3/0000696183, TS9423R3/0000703124, TS9423R3/0000724042, TS9425R38/0000675106, TS9425R38/0000687713, TS9425R38/0000687714, TS9425R38/0000696016, TS9425R38/0000705319, TS9425R38/0000707057, TS9425R38/0000716291, TS9425R38/0000726244, TS9749R27/0000680595, TS9749R27/0000683301, TS9749R27/0000690189, TS9749R27/0000695318, TS9749R27/0000699634, TS9749R27/0000712301, TS9749R27/0000713764, TS9749R27/0000716440, TS9749R27/0000720350, TS9749R27/0000724869, TS9749R27/0000726185, TS9781R11/0000665814, TS9781R12/0000676648, TS9781R12/0000681386, TS9781R12/0000691170, TS9781R12/0000700771, TS9781R12/0000711279, TS9781R12/0000725107, TS9800R30/0000674358, TS9800R30/0000674384, TS9800R30/0000675218, TS9800R30/0000681373, TS9800R30/0000685110, TS9800R30/0000690494, TS9800R30/0000701004, TS9800R30/0000711333, TS9800R30/0000721759, TS9806R11/0000665848, TS9806R11/0000667330, TS9806R11/0000673003, TS9807R23/0000683377, TS9807R23/0000685753, TS9807R23/0000692010, TS9807R23/0000700929, TS9807R23/0000712471, TS9807R23/0000725186, TS9818R23/0000667387, TS9818R24/0000680577, TS9818R24/0000684938, TS9818R24/0000692020, TS9818R24/0000712468, TS9818R24/0000725015, TS9824R16/0000712413, TS9824R16/0000723728, TS9824R16/0000725097, TS9917R27/0000662927, TS9950R21/0000675998, TS9950R21/0000685758, TS9950R21/0000698361, TS9950R21/0000717504, TS9959R12/0000662196, TS9959R12/0000673917, TS9959R12/0000683368, TS9959R12/0000689970, TS9959R13/0000693279, TS9959R13/0000697811, TS9959R13/0000707165, TS9959R13/0000710353, TS9959R13/0000723942, XP41BT/9904032, XP41T/9866739, XP41T/9874914.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution, including USA.
  • 제품 설명
    Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygenator with Trillium Biopassive Surface, with Plasma Resistant Fiber. MODEL Numbers: 95215, 95216, 95217, 95249, 95250, 95252, 0H46R28, 0M81R41, 0R35R13, 0Y95R22, 1702R51, 1A11R16, 1A19R26, 1B22R5, 1F66R12, 1G47R4, 1K86R3, 1K93R5, 1L71R20, 1M05R12, 1P07R6, 1X24R, 2892R18, 2D64R12, 2E55R9, 2N90R8, 2V85R4, 3B89R12, 3C98R7, 3P11R4, 3R39R2, 3R42R14, 4B46R16, 4E58R16, 4F13R2, 4J01R7, 4Q39R1, 4R68R5, 4R68R6, 4W65R, 4X44R7, 5633R30, 5C89R2, 5D83R, 5R69R1, 5U35R, 9059R20, 9243R19, CB0A12R15, CB2T58R4, CB3L15R5, CB4D99R4, CB4E05R6, CB4J24R2, CB4J67R1, CB4K47R1, CB4K64R5, CB5B53R, CB5C01R2, CB5C82R9, CB5P29R4, CB5Q88R, CB5S97R2, DP38T, HY0W55R17, HY0Y86R17, HY1709R34, HY1C73R16, HY2F13R22, HY2F13R23, HY2J04R2, HY2K12R5, HY2K16R5, HY2K51R14, HY2K60R3, HY2Q31R1, HY2Q32R2, HY2T49R3, HY2U43R5, HY2U98R5, HY2W85R9, HY3B29R13, HY3C53R1, HY3E77R13, HY3H52R13, HY3L42R12, HY3L78R1, HY3M41R4, HY3M43R1, HY3M45R1, HY3Q11R14, HY3T77R2, HY3U59R4, HY4A96R3, HY4B44R, HY4B50R, HY4E05R8, HY4E66R5, HY4V82R2, HY4X31R7, HY4Y15R11, HY4Z59R7, HY4Z62R5, HY5C74R15, HY5D07R, HY5D70R1, HY5L38R1, HY5N41R2, HY5N42R3, HY5P52R, HY5Q00R, HY5S13R, HY5S33R2, JP1Z53R11, M310113Q, M310319A, M310523D, M310525C, M310531G, M310538A, M310543F, M310824V, M310852C, M310854A, M311028K, M311224A, M311818C, M320234E, M320410V, M320608K, M321014K, M321505L, M322318C, M330112G, M330344D, M330607H, M332108C, M332607G, M333405W, M333809B, M334007C, M334007C, M334008D, M334209A, M335615B, M336202V, M337412A, M337414A, M337415A, M337417A, M337418B, M338001P, M340305C, M340615E, M343105G, M380324D, M390206E, M390322C, M390508D, M390824C, M391817L, M391817M, M391908B, M392814A, M392815A, M395216B, M395217B, M395319B, M396010D, M397013G, M397912B, M398309C, M399510A, M399511A, M410811K, M430737A, M443307B, M443822B, M443823B, M447005R, M460524D, M460530B, M460531B, M460532B, M462007B, M470233C, M470237C, M470945S, M470945T, M490750B, M495512K, M580211B, M580416B, M580418E, M720407F, M720409F, M720714C, M720718D, M720720B, M930401B, M930402B, M960116A, M960119A, M973502E, M973901C, M999308D, P391401B, TL0A42R21, TL0W56R7, TL1E95R12, TL1J50R3, TL2C82R4, TL2H89R7, TL2J77R, TL2K45R6, TL2L66R5 TL2L67R, TL2M25R6, TL2P63R1, TL2P93R5, TL2P94R9, TL2R00R3, TL2R66R, TL2S03R4, TL2S21R1, TL2S24R3, TL2S80R24, TL2S80R30, TL2S80R30, TL2T46R7, TL2U42R13, TL2U59R, TL2W21R, TL2W22R5, TL2W90R11, TL2Z00R4, TL2Z34R, TL2Z35R, TL3A08R16, TL3B47R8, TL3C66R4, TL3C69R16, TL3E97R5, TL3E98R7, TL3E99R2, TL3F17R2, TL3F33R1, TL3G03R2, TL3G89R1, TL3H76R12, TL3H85R1, TL3H86R6, || TL3K26R8, TL3L73R5, TL3M00R7, TL3M35R14, TL3M92R1, TL3N21R3, || TL3N58R1, TL3P08R4, TL3P79R8, TL3R32R4, TL3R79R4, TL3R82R6, || TL3R95R3, TL3S25R, TL3S39R3, TL3S63R, TL3T02R2, TL3T11R11, || TL3V10R11, TL3V42R6, TL3X14R3, TL3X14R4, TL3X86R5, TL3Y45R1, TL3Y70R1, TL3Y77R, TL3Z02R4, TL3Z07R, TL3Z67R4, TL4A55R19, TL4A76R, TL4A98R1, TL4B15R2, TL4B16R5, TL4C84R, TL4D71R1, TL4E06R1, TL4E30R11, TL4F57R2, TL4F60R, TL4F71R1, TL4F88R6, TL4F97R7, TL4H65R, TL4H98R1, TL4J16R, TL4J32R10, TL4J96R7, TL4K33R3, TL4K78R, TL4K84R8, TL4K88R, TL4K93R, TL4K95R3, TL4L34R4, TL4M16R2, TL4M22R10, TL4M94R5, TL4N20R10, TL4N27R3, TL4N84R, TL4P48R2, TL4P64R4, TL4Q43R3, TL4Q43R4, TL4R10R2, TL4R21R, TL4S97R8, TL4T06R3, TL4U93R7, TL4V76R1, TL4V77R, TL4W07R4, TL4W22R, TL4W94R1, TL4X63R1, TL4X99R8, TL4Y20R2, TL4Z28R2, TL5054R11, TL5263R2, TL5398R19, TL5398R20, TL5A39R3, TL5B82R1, TL5B83R1, TL5C29R2, TL5C35R6, TL5C63R2, TL5C64R3, TL5C97R6, TL5D45R4, TL5D65R, TL5D66R3, TL5E04R, TL5E11R1, TL5F48R, TL5F62R5, TL5F64R4, TL5F96R, TL5G03R2, TL5G04R2, TL5G26R1, TL5G27R, TL5G27R1, TL5G41R2, TL5H55R1, TL5J24R6, TL5J74R2, TL5L27R1, TL5N42R2, TL5N43R3, TL5N53R1, TL5N59R, TL5N60R, TL5N62R4, TL5N79R, TL5N94R, TL5P14R, TL5P59R2, TL5P73R2, TL5P76R2, TL5Q40R1, TL5Q76R3, TL5Q85R2, TL5Q89R1, TL5R08R, TL5R15R2, TL5R18R1, TL5R52R, TL5R57R1, TL5R91R5, TL5S53R, TL5T73R, TL5U33R, TS1259R14, TS1259R15, TS1366R3, TS1366R4, TS1366R5, TS1404R1, TS1414R3, TS1420R
  • Manufacturer