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
FDA Recall Z-2005-2008 · Posted 2008-07-30
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Recalling FirmMedtronic International Trade Inc
Recall StatusTerminated
Product CodeDRY
Date Initiated2008-05-07
Date Terminated2008-12-01
Product Quantity59500
Reason for Recall
Medtronic is advising that certain Trillium-coated Medtronic cardiopulmonary bypass (CBP) products (e.g., oxygenators, reservoirs, pumps and tubing packs) were manufactured with heparin batches contaminated with oversulfated chondroitin sulfate (OSCS). Based upon currently available information, Medtronic has determined that Medtronic Trillium-coated products can continue to be used in cardiopulm
Firm Action
Medtronic Cardiovascular Customers were sent the May 05, 2008 Urgent Medical Device Corrective Action letter to advise them that certain Trillium-coated cardiopulmonary bypass products were manufactured with heparin which may be contaminated with oversulfated chondroitin sulfate. The letter discussed the risk evaluation and gave recommendations to healthcare professionals for patient care. Affected devices can continue to be used in cardiopulmonary bypass procedures.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution, including USA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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