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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Medtronic Perfusion Systems: An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.

Agency Publication Date: January 27, 2023
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Affected Products

Product: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

Model BB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00643169178168 (Lot Numbers: 13386860, 13386998, 13387454, 223834103, 224773022, 224773023, 225467084, 225467085); GTIN Number: 00643169178175 (Lot Number: 13388339, 13389098, 13394289, 223815345, 223829391, 223834104, 223834105, 224602715, 224695594, 224702830, 224711400, 224773018, 224773019, 224773020, 224773021, 224875617, 224883237, 224893902)

Lot Numbers:
Numbers
Number
Product: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.

Model BB841; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00643169354869 (Lot Numbers: 13384637, 13385152, 13385470, 13385745, 13385981, 13386194, 13386335, 13386747, 13386941, 13387068, 13387247, 13387298, 13387483, 13387670, 13387792, 13388008, 13388227, 13389074, 13389305, 13389823, 13389827, 13390010, 13390330, 13390505, 13390516, 13390751, 13391244, 13391264, 13391564, 13392146, 13392253, 13392727, 13393000, 13393036, 13393583, 13393871, 13394240, 13394370, 13394371, 13394424, 13394642, 13394972, 13395023, 13395803, 13395855, 13395924, 13396141, 13396262, 223431961, 223431962, 223476434, 223476435, 223525108, 223525109, 223525110, 223662140, 223662141, 223662142, 223662143, 223662144, 223746776, 223748866, 223751647, 223753656, 223753657, 223753658, 223753659, 223779522, 223782425, 223785172, 223790984, 223799185, 223800819, 223800886, 223806602, 223808121, 223812498, 223834087, 223834088, 223834089, 223834090, 223923171, 224046843, 224049195, 224060623, 224062467, 224071460, 224078980, 224087129, 224097013, 224169153, 224173725, 224180684, 224189083, 224198472, 224207770, 224217125, 224229400, 224229401, 224351135, 224384707, 224391477, 224401622, 224414139, 224428547, 224434720, 224459327, 224465687, 224469080, 224555817, 224562193, 224568610, 224571733, 224582640, 224591854, 224600536, 224609441, 224620065, 224629824, 224673589, 224673593, 224694993, 224702972, 224715756, 224722879, 224730837, 224736123, 224746679, 224754722, 224772850, 224772851, 224772852, 224772853, 224772854, 224772855, 224772856, 224772857, 224772858, 224772859, 224772860, 224772861, 224772862, 224772863, 224772864, 224772865, 224772886, 224772887, 224772889, 224772890, 224772891, 224772892, 224772893, 224772895, 224772896, 224772897, 225020112, 225209644, 225209645, 225210026, 225332480, 225332481, 225332482, 225332483); GTIN Number: 00643169354883 (Lot Numbers: 13384723, 13384730, 13384881, 13384976, 13385583, 13385767, 13385867, 13386228, 13386478, 13388449, 13388452, 13388544, 13388598, 13389191, 13389598, 13389870, 13390168, 13390640, 13390684, 13390874, 13390984, 13391365, 13391390, 13391663, 13391937, 13392221, 13392464, 13392614, 13392903, 13392975, 13393065, 13393176, 13393342, 13393342, 13393658, 13393890, 13393921, 13394029, 13394151, 13394821, 13395330, 13395332, 13395410, 13395461, 13395524, 13395771, 223388884, 223392415, 223392423, 223392435, 223431964, 223431965, 223431986, 223476436, 223476437, 223476438, 223476439, 223476439, 223476440, 223523220, 223523221, 223523222, 223523223, 223523224, 223523225, 223525106, 223525107, 223637178, 223641990, 223650772, 223660380, 223662145, 223662186, 223662187, 223662188, 223662189, 223662190, 223662191, 223723553, 223738421, 223750562, 223753660, 223753661, 223753662, 223753663, 223753664, 223753967, 223755426, 223755427, 223755428, 223833251, 223833256, 223834091, 223834092, 223834093, 223834094, 223834095, 223834096, 223872428, 223878290, 223878291, 223883408, 223893771, 223898271, 223903420, 223905400, 223913345, 223914588, 223928428, 223936394, 223939036, 223947101, 223953209, 223961794, 223964866, 223972811, 223981604, 223995093, 223995666, 224000958, 224006521, 224006951, 224011284, 224011625, 224011646, 224011647, 224011648, 224011649, 224011650, 224101106, 224236728, 224253937, 224312807, 224323095, 224331329, 224334991, 224346525, 224356382, 224356383, 224372815, 224475835, 224478783, 224484698, 224494813, 224506201, 224511441, 224518515, 224526165, 224526860, 224532203, 224535429, 224544419, 224630603, 224630604, 224644422, 224673817, 224686850, 224763409, 224771068, 224772898, 224772899, 224772900, 224772901, 224772902, 224772903, 224772904, 224772905, 224772926, 224772927, 224772928, 224772929, 224772930, 224772931, 224772932, 224772933, 224772935, 224772936, 224772937, 224772940, 224772942, 224772943, 224772944, 224772945, 224772986, 225090558, 225090559, 225090560, 225162245, 225162946, 225174904, 225174905, 225176086, 225294537, 225294539, 225294541, 225294543, 225294544, 225332485, 225332486, 225332487, 225332488, 225332489); GTIN Number: 00643169588660(Lot Numbers: 13385981, 13387247, 13387483, 13387792, 13389305, 13389823, 13389827, 13390516, 13390751, 13391244, 13391564, 13394370, 13394424, 13395924, 223476434, 223662140, 223662144, 223961794, 224087129, 224401622, 224526860, 224772929, 225020112, 225090559, 225162245, 225162946)

Lot Numbers:
Numbers
Numbers
Numbers
Product: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.

Model CB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00763000225476 (Lot Numbers: 225313243, 225400271, 225467451, 225467452); GTIN Number: 00763000225483 (Lot Numbers: 13392578, 13394967, 224274665, 224426764, 225332708, 225332709, 225467446, 225467447)

Lot Numbers:
Numbers
Numbers
Product: Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.

Model CB841; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00763000225452 (Lot Numbers: 13394614, 13395228, 223819363, 223952969, 224315522, 224448403, 224772847, 224772848, 224772849); GTIN Number: 00763000225469 (Lot Numbers: 13392615, 13394868, 223476442, 223755429, 223796291, 223834097, 223834098, 224174020, 224188890, 224365018, 224419842, 224816179, 225222080, 225273494, 225273495, 225331432, 225332504, 225332505, 225332506, 225332508, 225661147)

Lot Numbers:
Numbers
Numbers
Product: Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.

Oxygenator Model BB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number, Tubing Pack Model Number (Lot Numbers): 00643169231948, M390082B (223422891, 223952683, 225651632); 00643169345379, M961233A (223537804); 00643169422025, M445428F (223378929, 223672423, 223909336, 224399508, 224695321, 225303449, 225434680); 00643169439269, M274805B (223714089, 224907239); 00643169449442, BB6U40R11 (223728548, 224155209, 224539886, 224794461); 00643169469495, BB4Q12R15 (223612682, 224026310); 00643169572263, HY8L55R5 (225033983, 225033984, 225045278, 225126456); 00643169583542, M330119D (223547370, 224206448, 225484644); 00643169621473, BB8U95R1 (223488691, 223764562, 225251346); 00643169622715, BB8B70R7 (224281969, 224664696); 00643169632097, M721107D (223538837, 223588897, 224380964, 224567880, 225089620, 225528159); 00643169639027, BB3X42R13 (223558525, 223896827, 224155078, 224664710, 224815782); 00643169645424, BB8M16R3 (224155078); 00643169674486, M722001A (223614712, 224077488, 225161996); 00643169692893, BB8P01R7 (223066047, 223644491, 223983902, 224573049, 225047877); 00643169711945, BB8T77R2 (223283021, 224497848); 00643169717336, BB8Q09R2 (223054336, 223206892, 223409300, 223573934, 223804327, 223896843, 224066169, 224327204, 224664704, 224664705, 224985026, 225170609); 00643169750883, BB8J66R17 (222974930, 222974932, 223206895, 223274762, 224066185, 224282025, 224454020, 224539805, 224752687, 224838236, 224838238); 00643169793699, BB8C33R6 (223234986, 224281982); 00643169793927, BB8M48R5 (223685618, 223833474, 224963605); 00643169840058, M342615P (223630909, 224033583, 224311665, 224567877, 225048104, 225303159, 225484317); 00643169860643, M482903D (223672424, 223969961, 224312691, 224735824, 225207742, 225561384); 00643169865365, BB9D32R2 (223033102, 223127174, 223488375, 223851344, 224233682, 224281957, 224573053, 224794262, 224794263); 00643169872127, BB9L72R1 (223145738, 223631537, 223896364, 224664748, 224923414, 225126448); 00643169876743, BB9B43R3 (223573837, 224794493); 00643169876903, BB8U52R8 (223728547, 224281942, 224473476); 00643169955790, BB3M00R30 (223896474, 224497817, 225047868); 00643169957008, M483002C (223508310, 223815840, 224008812, 224075857, 224992815, 225161643, 225560932); 00643169998643, BB9J85R3 (222974878, 223728616, 224442258, 224963603); 00763000006884, M721902F (223665117, 224069967); 00763000008215, BB8E47R17 (223896458, 224582573); 00763000014001, M059709E (223808314); 00763000014971, HY9E07R9 (223006393, 223764172, 224497852, 225047918); 00763000016944, M447026J (223311071, 224033576, 224525725, 225089619); 00763000021887, M450202J (223378878, 223482251, 223569832, 223695950, 224399265, 224695323, 224948490, 225208459); 00763000024406, BB9N31R3 (223323272, 223603527, 224414960); 00763000025878, BB4B15R14 (223283065, 224066162, 224497806, 225219652); 00763000026240, BB10D95R (224923422); 00763000062613, M233101D (223926251); 00763000062637, M233105F (223926253); 00763000064242, M447708H (223240765, 223909585, 224252242, 224567886, 224736688, 225209646, 225436092, 225651518); 00763000077747, HY0W84R31 (225059180); 00763000099831, BB10B90R6 (223283006, 224277441, 224752773); 00763000112035, M412501B (224115258, 224465727, 224736967, 225303530); 00763000118914, BB8P23R4 (223112645, 224154996, 225104523, 225398699); 00763000126315, BB10H89R4 (223498029, 223896315); 00763000133030, HY9S48R4 (223060795); 00763000135348, BB7J04R11 (223112635, 223603534, 224327223, 224539803, 224811484); 00763000135355, BB8H01R4 (224155218, 224476527, 224923391); 00763000139513, BB8N34R6 (222974686, 223409294, 224019319, 224516511); 00763000139742, M720109G (223378927, 223532940, 224122998, 224652776, 224907237, 225254267); 00763000141363, BB9R53R7 (223235051, 224370597); 00763000155353, BB8C53R12 (222982219, 223558532, 223728602); 00763000159504, M273508D (223994900, 225049328); 00763000162245, M371203C (223540014, 223953001, 224865428, 225346409); 00763000175726, HY10G12R7 (223558545); 00763000178048, BB7Y33R8 (223014654, 223196558, 225047919); 00763000186180, M410209L (223422890, 223969951, 224337397, 224993580); 00763000188276, BB8G43R7 (223342946, 223922491, 224497816, 224923386); 00763000201159, BB8P06R10 (223282994, 223558454, 224281953, 224582631); 00763000201456, BB10S84R (223014671, 223165007, 223206893, 223896868, 224539690); 00763000203405, M391414L (223439639, 224008699, 225065951, 225254280); 00763000211271, HY9R12R13 (224112059); 00763000214531, M331107A (225049339); 00763000224349, BB0E27R32 (223165010); 00763000231538, BB2493R44 (222918292, 223169854, 223558505); 00763000233259, HY5V41R21 (225008158); 00763000234911, BB10P38R2 (222980256, 223728607, 224281988); 00763000236588, HY7E57R17 (224923409); 00763000245351, M495523C (224993583); 00763000246914, M483804B (223508320, 224123002, 225228308); 00763000252663, M721333F (223385805, 223816583, 225331628); 00763000255220, BB8Q56R7 (223044144, 223498060, 223939254, 223967258, 224327237, 224582569, 225086642); 00763000256739, BB8D44R6 (223014665, 223366534, 223896431, 224282016, 224664764, 225270451); 00763000258535, BB10X94R1 (223014672, 223939240, 225170565); 00763000260217, BB8L80R5 (223804388, 224282106, 224752767, 224827938); 00763000262372, BB8X02R9 (223728556, 224282007, 225047878); 00763000263799, BB10S31R3 (223748240, 224196599); 00763000273026, BB8E21R10 223196716); 00763000274610, BB8M09R1 (223645439, 223764064); 00763000275259, BB6M22R15 (224752717); 00763000275341, BB4Z62R19 (223113114, 223728590, 224155206, 224196598, 224370575, 224370576, 224838243, 225008581, 225126482); 00763000276010, BB10V32R (223728486, 223833388, 224758658, 224826799); 00763000280277, M344803C (223648108); 00763000286897, BB10Y67R3 (223234951, 223454165, 224155184, 224539899); 00763000287948, HY9G02R4 (224963556); 00763000288266, HY7W91R22 (225047922); 00763000291839, M337709C (223753451, 224252233, 224948527, 225484643); 00763000293796, BB7H73R17 (223066046, 223334261, 223983917); 00763000299064, BB10S01R2 (225008518); 00763000299859, HY10W55R4 (223060796, 223742623, 223896428); 00763000300692, BB8B96R14 (223095081, 223308375, 223851415, 224327302, 224727367, 224727381); 00763000300937, P490302G (223952674); 00763000316976, HY7V82R20 (225126488, 225126489, 225126490); 00763000319984, HY10S39R3 (223983866); 00763000324773, BB8C09R8 (223409262, 224539793); 00763000325190, M075502A (224419078); 00763000334079, BB10E61R4 (223196718, 223558523, 224281959, 224681554, 225047867); 00763000334710, M612704H (223589853, 224048919, 224399524, 224644262, 225528147); 00763000339319, BB10X57R2 (222974895, 223283046, 223685655, 224281979, 224623803, 225170602); 00763000339319, BB10X57R2 (224794435); 00763000339982, M490645H (223393275, 223713005, 223862637, 224033582, 224337395); 00763000341053, M343105N (223241295, 224188635, 225651514); 00763000343088, M390728D (223712998, 224206461, 225120479, 225303518); 00763000343101, M333715H (223508318); 00763000343125, M391714B (223245021, 223521591, 224096698); 00763000344467, HY2U43R17 (222918489, 223366491, 224019352, 224582540); 00763000345082, BB11D80R (223366501, 223922494, 224582570); 00763000345341, M341506M (223752205, 224493232, 224865426, 225303515); 00763000346478, BB10P64R2 (223054331, 223054338, 223939276, 224454048, 224879178); 00763000346508, BB10N96R9 (223039591, 223409295, 223851363, 224282011, 224664692); 00763000347468, M393929B (224008686); 00763000351632, M322226B (223311076, 223837958, 224652840); 00763000353988, BB8B99R6 (223014674, 223054435, 223283257, 223728610, 224066167, 224281974, 224454133, 224582611, 224784931, 224827935); 00763000361631, BB10V51R6 (223644493, 224026309, 224327297, 224582608, 225126484); 00763000362119, BB11A97R2 (223100965, 223232472, 223323298, 223366554, 223558497, 223558498, 223558499, 224112033, 224281950, 224370559, 224454051, 224454052, 224539876, 224794434, 224963551, 224963552, 225270478); 00763000365837, BB11C80R1 (223234952, 223728861, 224281954, 224827933, 224908927, 225398632); 00763000367671, HY10R64R10 (224794438); 00763000369798, BB10R29R9 (223283067, 223764143, 224155201, 224281965, 224438188, 224807342); 00763000371456, BB1A19R53 (223127717, 223558636, 223741575, 224005631, 224370568, 224370569, 224623765, 225086681); 00763000373955, BB8G55R15 (225170562); 00763000378493, BB11E97R1 (223939212); 00763000378707, BB8D19R9 (223851379, 224752796, 225443660); 00763000400071, BB5N63R5 (224111962, 224497871, 225126503, 225219702); 00763000400576, BB10Y59R9 (223644492, 224497855, 225408501); 00763000401979, M632007A (223552152, 223552153, 224033798); 00763000402501, M483507A (223422023, 223862847, 224224164, 224297726, 224907140, 225090699, 225346302, 225651635); 00763000404062, M075204A (223482693); 00763000404239, M494833G (223466603, 223612884, 223695960, 224865316, 225389397); 00763000408343, HY8T43R9 (222991247, 222991247, 223093372, 223093372, 223728599, 223728599, 223851364, 223896429, 223896429, 224019182, 224019182, 224019183, 224019183, 224019184, 224019184, 224370593, 224370593, 224370594, 224370594, 224497860, 224497860); 00763000408350, BB7V97R15 (223033103, 223196545, 223498044, 223603535, 223983880, 224232482, 224232482, 224281943, 224327276, 224370542, 224370543, 224497755, 224497756, 224497756, 224794357, 224794357, 224794358, 224794358, 225126493); 00763000408824, M964503C (223484468, 224711012); 00763000412128, M334211F (225651640); 00763000412838, BB10L76R4 (223323277, 224155000, 224794449); 00763000412883, BB8W14R8 (223093369, 223206888, 223488706, 223764171, 223931082, 224243204, 224529301, 224529301); 00763000415518, M442233G (223521613, 223882114, 224225700, 224610491); 00763000416355, BB10Q99R11 (223026452, 223206896, 223366549, 223685610, 223685611, 224112042, 224282010, 224454017, 224539762, 224565388, 224879086, 225086646, 225311198); 00763000416980, HY11G55R1 (223558536, 223983966, 224370546, 224370547, 224963529); 00763000417642, M720727L (223672425, 223881861, 224652780, 225161916); 00763000417666, M720413J (225049343); 00763000418649, BB8E17R7 (224019348, 224019348, 224170585, 224327212, 224539786, 224539786, 224879115, 224879115); 00763000418748, M333816C (224206455); 00763000425760, BB10R49R6 (223054433, 223103737, 223764138, 224170582, 224281990, 224539789, 224794453, 225219686); 00763000426002, HY11E26R3 (222724087); 00763000426354, BB5Z97R18 (222998309, 223172628, 223804414, 224281949, 224370558, 224923413); 00763000428488, HY10H88R12 (223343008, 223764185, 224327202, 224794432); 00763000428716, BB3V10R34 (224282013); 00763000429058, M445885K (223352900, 223466329, 223815842, 224138282, 224652778, 225041058, 225436095); 00763000431570, HY10L69R7 (223173597, 223685788, 223685788); 00763000431822, M450311U (223303584, 223837444, 223908982); 00763000431839, M342507G (224865311, 225651642); 00763000431860, M422114D (224652877, 225273957); 00763000431877, M340615R (223393278, 223714094, 224096966, 224337418, 225090362, 225484631); 00763000432638, BB8S31R13 (223983970, 224923408); 00763000432669, HY11L82R1 (223366499, 223896483); 00763000432959, M330416E (223881865, 224048911, 224397994, 224865226, 225254273, 225447057); 00763000436612, M332410K (223864228); 00763000439828, BB5U30R11 (223366471, 224539686); 00763000439835, BB8U85R3 (223112591, 224539693); 00763000442613, P393001E (223260994, 223775521, 224206457, 224736692, 225346296); 00763000442750, M346203E (223508309, 223881863, 224047764, 225040700, 225434676, 225651643); 00763000445904, BB10J28R7 (223558533, 224327244, 225086634); 00763000455149, M399004Q (223714088, 224695402, 225208455); 00763000458072, HY10N63R6 (222755419, 224388050); 00763000458164, BB11A61R3 (223558486, 224112029, 224497813, 225008562); 00763000467074, BB8B22R14 (223002552); 00763000467487, M482406A (223532934, 223837990, 224252237, 225161991, 225651629); 00763000474058, BB9G98R8 (224196587, 224578585, 225170623); 00763000479428, M332831G (223303585, 223753452, 223993384, 224225698, 224865200); 00763000479626, BB11G35R3 (224826824); 00763000486723, M336213Q (223881862, 225120380, 225651512); 00763000486730, M336214P (223862062, 224077482, 224736686, 225120379, 225303457); 00763000487829, M331404M (223538843, 224271884, 225303512, 225534098); 00763000496548, P391802L (223508314, 223656860, 224271882, 224695307, 224865236, 225346288); 00763000497781, M342122D (223393281, 224297748, 224865238, 225434678); 00763000498443, HY10V75R8 (224028722, 224282020); 00763000498573, BB0Y86R39 (223558527, 224196574); 00763000499129, BB7U03R21 (223196579, 223685659, 223922497, 224327326, 224453934, 224923398); 00763000500962, BB10R11R5 (223095082, 223128090, 223323299, 223728558, 223728560, 223728561, 224112093, 224370601, 224370602, 224714330, 224794452, 225008565, 225008566, 225311121); 00763000501068, HY3P08R39 (224838255); 00763000501228, M337435C (223352899, 223713000, 223969950, 224652842, 224948504, 225389455); 00763000504137, M390361E (225331250); 00763000505417, HY2J36R23 (224923390); 00763000513214, BB10B05R15 (223305124, 224066122, 224539897, 225047883); 00763000516727, HY9D67R2 (223031034, 223093366); 00763000517854, HY9G55R5 (224743163, 225021492); 00763000518806, M411612T (223753453, 224033606); 00763000519254, BB8A70R13 (223127551, 223939277, 224664769); 00763000519919, P391805A (224456637); 00763000520205, M336111P (223735980); 00763000522810, M447215M (224096703, 224568266, 224948492); 00763000523176, HY10W75R5 (222899602, 223173593, 223409284); 00763000523213, M330211J (223789662, 224252239); 00763000524104, M330523B (223588904, 223735983); 00763000530419, BB8D56R15 (223127555, 223410326, 223728600, 224066161, 224282110, 224521225, 224743169, 224827932, 224908617, 224908618); 00763000532581, M331247C (223465272, 223789253, 224122616, 224225693, 224967449, 225354449); 00763000532680, BB9L88R22 (223054337, 224155210, 224327335, 224539788, 224879149); 00763000534561, HY6V44R36 (224699965, 224794363); 00763000535001, HY9L07R6 (224664715, 224996019); 00763000535018, HY9L80R6 (224453920, 224743173, 225008586); 00763000535070, HY8C67R16 (223112636, 223707560, 224196557, 224582609, 225086663); 00763000535407, BB8L56R9 (223138510, 224730556, 224732557); 00763000535841, HY1W12R36 (224963549); 00763000536206, HY10U52R7 (223196721, 223196722, 223196723, 223326043, 223326045, 223746645, 223747906, 223747907); 00763000539702, M300014B (223507398, 223862852, 224907229); 00763000541378, M337503Q (223612883, 223862855); 00763000541392, M336912J (224381033); 00763000542139, HY10U10R4 (223366492, 223804331, 224539881, 225008574); 00763000542146, HY10Q87R8 (223012945, 223650970, 224794440, 225219608); 00763000542153, HY10E56R13 (223366510, 223830711, 224281963, 224743174); 00763000542269, BB9H96R3 (224327205, 224838209); 00763000542566, BB11P45R5 (223189916); 00763000543969, HY11A91R9 (223155619, 223409261); 00763000544263, HY10B82R16 (223830712, 224327221, 224699948, 224811567); 00763000544379, HY7F85R17 (223112638, 223603565, 224281946, 224454057, 224879063); 00763000544546, M338803F (224096967, 224312701, 224735821); 00763000544607, M964909D (223547368, 224123953); 00763000544652, M332025J (223439636, 224138275, 224399257, 225049336, 225208457, 225651630); 00763000545888, BB9N38R9 (223173688, 223173689, 223283246, 223283247); 00763000546076, HY9Q42R9 (223196621, 224019281, 224327281, 224752724); 00763000546199, HY10U97R10 (223014745, 223685653, 223870495, 224066196, 224414982, 224830253, 224861214); 00763000549374, BB8X22R4 (223939262); 00763000550813, M343810D (223438639, 223589851, 224068598, 225303523); 00763000550837, M338014C (223422894, 223995012, 224948502, 225494182); 00763000550844, M335007M (223507401, 223588899, 223862632, 224007264, 224122615, 224312692, 224695542, 225161923); 00763000552015, BB1P07R23 (223830708, 224154987, 224794356); 00763000552060, M333715J (223745705, 224206458, 224780960, 225209647, 225436097); 00763000553890, M395912L (223508306, 224033577, 224736704, 225207739, 225561606); 00763000554095, HY7Z58R14 (223014656); 00763000554248, P392015A (223630915, 223918199); 00763000554286, BB2Q31R9 (224281952, 224923412); 00763000557171, BB1F66R24 (223283000, 224539887, 224963554); 00763000557188, HY4953R29 (224752787); 00763000557614, HY10X07R7 (223173591, 224135886); 00763000557621, HY10Z53R7 (223601660, 224415005); 00763000558413, BB8L58R13 (223066090, 223728552, 223896437); 00763000559687, M334908J (223672420, 223815906, 224440775, 224568270); 00763000564148, BB9H23R19 (223113115, 223644476, 224112056); 00763000564377, BB3C53R17 (223764130); 00763000569129, BB8W70R13 (222974838, 223663194, 223685567); 00763000573201, BB8S37R32 (222941495, 223558463, 224370599, 224752788); 00763000573836, BB0C80R37 (223112532); 00763000574079, HY10V50R1 (224734918); 00763000574666, BB8P76R4 (222941500, 223366541, 224066146, 224414946); 00763000576684, BB8P98R5 (223323355, 223983884, 224573409, 225170604); 00763000576752, HY11R94R1 (225270471); 00763000578329, HY11R00R6 (224784927, 224963587, 225270476, 225270477); 00763000578466, HY8N78R5 (224794445, 225398668); 00763000580698, BB10Q73R5 (223323133, 223873281); 00763000580704, BB11R26R (223323134, 223872619); 00763000582913, BB1D41R30 (223366508, 224155004, 224582627, 225086671); 00763000583002, BB6H26R40 (222916985, 223341605, 223804397, 224539866, 224796510, 224912392, 225086643); 00763000586645, M494516D (224865234); 00763000586669, HY9N98R14 (222974890, 223764201, 224281967, 224497786); 00763000589738, BB10J17R10 (223145657, 223851413, 224066181, 225337326); 00763000595319, M449117G (223790476, 224188645, 224865227, 225254269); 00763000596644, M333924W (223547374, 224168530, 224380962, 224695528, 224947972, 225090704, 225254278); 00763000597801, M411615A (223423119, 223745948); 00763000597818, M310892A (224907235; 00763000597870, HY10Q64R8 (223026510); 00763000600174, HY11P17R5 (223558538, 224453944, 224923387, 225219637); 00763000602666, HY9D67R3 (223254163, 223682449, 223682450, 224454019, 224539833, 224539834, 225270458); 00763000603021, M962803D (223393270, 224048912, 224711010); 00763000605193, HY7Z58R16 (223173685, 223196574); 00763000605292, BB11G87R3 (223130151, 223130152, 223558578, 224155216, 224282109, 224539801); 00763000606190, BB11S82R (223323219); 00763000608828, BB8B22R15 (223742624, 223744002, 223905178, 223983858, 223983859, 224066123, 224539888, 224664687, 224794427, 225008580, 225219626); 00763000608859, HY11Q67R2 (223213010, 224196590, 224730552); 00763000608958, M330350Q (223508315); 00763000611149, M337503R (224188641, 224651362); 00763000611170, M495422B (224012294); 00763000611293, BB11F25R2 (223939299, 224154913, 224908625); 00763000611644, M348104C (224679126, 225074770); 00763000611712, BB11A90R2 (223282899); 00763000612856, BB1845R50 (223282947, 223983968, 224281989, 224752778, 225219654); 00763000612931, M333519H (223837952); 00763000615284, HY9M47R19 (224854723, 225035305, 225035368, 225035675); 00763000616199, M382708B (223544697); 00763000616212, M310640B (223423007, 223631052); 00763000618735, BB11U53R (223341589, 223341591, 223341592, 223409251, 223498039, 223498041, 224664657, 224664658, 225169142, 225169143, 225169144, 225377168, 225377169, 225377170); 00763000618803, BB11T08R1 (223645659, 223804310, 224066091); 00763000619015, BB9H27R7 (223441265, 223833392, 223983162); 00763000620769, M311244B (223630911, 224048946, 224380961, 224960126, 225463283); 00763000620813, BB11U58R (223397188, 223558408, 223558409, 225170560, 225443635); 00763000625078, M331712E (224033569, 224354073, 224492614, 225651506); 00763000625092, M330521Q (223457947, 223968625, 224048947, 224206462, 224651361, 224907236, 225303452); 00763000625122, BB0E27R33 (223454120, 223939279, 224370583, 224730553, 224732556, 224908623); 00763000629878, HY11U75R2 (223463274, 223463275, 223463276); 00763000630225, BB11S99R2 (223462993, 223993306, 224277445, 224722407); 00763000632847, HY11V34R (224854721); 00763000633479, BB11V07R1 (223513739); 00763000633875, HY10W75R6 (223463269); 00763000633882, HY11A91R10 (223610879, 223610881, 223611017, 223613147, 223685787, 223896449, 223896450, 224066148, 224066149, 224066150, 224066151, 224344276, 224414993, 224414994); 00763000633899, M720623G (224047763, 224297736, 224610674); 00763000635022, M391908L (223575405, 223753454, 223862627, 224419073); 00763000637866, BB11V07R2 (223764559, 224539870, 224752793); 00763000637927, BB11L42R1 (224141302, 225270452); 00763000638924, BB7U21R21 (223764133, 224155079, 224794467); 00763000639181, M370519D (224330674); 00763000639815, M340208E (224217489); 00763000639846, BB11V67R1 (223666340, 223666343); 00763000640071, BB9H69R8 (223896478, 224327288, 224963527); 00763000640125, M382708C (223783763, 223908975, 224312702, 224865429, 225254287); 00763000640507, BB11V28R1 (223701901, 224019311, 224282009, 224752804); 00763000641962, M485003D (223784075); 00763000643768, BB11L73R5 (224674341); 00763000643775, HY10V01R7 (223905173); 00763000643782, HY11C28R10 (223858951, 224028723, 224344272, 224414996); 00763000643799, HY11R97R2 (223905172); 00763000644284, BB10Y64R5 (223804308, 223939219); 00763000645250, BB11V20R2 (223856935, 225398671); 00763000646721, M336310H (223995011, 224188639, 224390526); 00763000646981, BB10Q03R3 (224066077, 224146340, 225251243); 00763000647117, M450311W (224206729, 224864023, 225048105, 225253865, 225484319); 00763000647162, P392021A (224151381, 225049326); 00763000648350, HY9E87R10 (225086647); 00763000648428, BB11U86R1 (223911691, 224623750); 00763000648602, BB2493R47 (223931081, 224752712); 00763000648930, HY11U21R3 (225008555); 00763000650599, HY10U52R8 (224066188, 224066189, 224155193, 224387583, 224539898, 224582637, 224862882, 224862883, 224862884, 224862885, 225141913, 225141914, 225141915); 00763000651183, HY7Z58R17 (224277397, 224282101, 224861612); 00763000654740, M614023E (224396995, 225032739, 225338014); 00763000655174, BB8E21R11 (224071038); 00763000656072, BB11V68R2 (224134370, 224281886); 00763000657741, BB5W51R9 (224036258, 224155174, 224370604, 224827939); 00763000657765, BB8X22R9 (224879057); 00763000658588, BB11P45R9 (224061837, 224277423, 224277424, 224573050, 224752680, 224963533, 224963534); 00763000658601, P393216D (224115431);00763000658892, BB11W98R1 (224080416, 224539746); 00763000659585, BB11X15R1 (224082690, 224082693, 225104524); 00763000661083, M310640D (225090773); 00763000661090, M332410L (225494174); 00763000661106, M333519J (224297740); 00763000661489, BB11W97R2 (224277360, 224277361, 224838240); 00763000661496, BB8C31R5 (224162781, 224282090, 225008585, 225170614); 00763000661519, M330350R (224399249, 224610322, 224864022, 225161642, 225398438); 00763000663766, M411612U (224297712, 225041048, 225561517); 00763000665982, BB11V67R3 (224277390, 224539906); 00763000668211, P490607L (225090698); 00763000687632, BB11W30R5 (224277402, 224277403, 224664754, 225008582); 00763000687687, BB11T08R2 (224281905, 224327484, 224327485, 224582574, 224743165); 00763000687915, HY11N01R1 (224387577); 00763000687953, M331709P (224297524, 224381034, 224679487, 225463282); 00763000688158, HY2S09R20 (225126455); 00763000688844, HY11B96R3 (224453919, 224838220); 00763000689070, HY11S98R1 (224415022); 00763000689094, M448913A (224544065); 00763000689100, M484610A (224865433, 225389400); 00763000689148, BB11W92R1 (224313925, 224539703, 224752706); 00763000689377, BB5C09R10 (224327240, 224391692, 224453928, 224453930, 224539841); 00763000689445, BB11V88R2 (224327483, 224963599, 225492104); 00763000689919, BB11X99R2 (224303174, 225008572); 00763000699697, BB11X05R1 (224539844); 00763000699703, BB10J83R6 (225398707); 00763000700546, BB9N38R12 (224334590, 224414911, 224414913, 225126467, 225353756); 00763000701321, M310643G (225220421); 00763000701963, M614026B (224644207); 00763000702014, M490645J (224567874, 224865202, 225303451); 00763000702021, M470734A (224948453); 00763000702038, M460236G (224993570); 00763000702052, M252003C (224417843); 00763000703523, M410714C (224448472); 00763000704841, HY11W65R1 (224794464); 00763000704858, BB11W56R3 (224453916, 224453917); 00763000704865, BB11U19R4 (225425032); 00763000708191, BB8E21R13 (224463906, 224838241); 00763000712648, M336310J (224594409, 224594410); 00763000712716, HY10P39R5 (224794455); 00763000715366, M470879A (224948493); 00763000715748, BB11W98R2 (225047920); 00763000716196, HY9N98R16 (224875405); 00763000716684, HY11T97R6 (224752585); 00763000717629, HY2G71R7 (224664460); 00763000718862, BB0Y86R40 (224963528); 00763000721275, BB10S31R5 (224752674, 225270475); 00763000721374, BB10Y07R9 (225170628); 00763000723675, BB3C53R18 (224794252); 00763000723989, BB11S99R10 (225270581); 00763000724597, BB11V07R3 (225311189); 00763000726317, BB11U86R3 (224845842, 224980052); 00763000727307, HY10V01R8 (224734919, 224734920, 224734921); 00763000734251, BB11Z74R (225270369); 00763000736408, M484904D (225050406, 225210946); 00763000740214, M233110B (225227873); 00763000740320, BB11U86R5 (225008508); 00763000740900, M310566F (225330362); 00763000743406, M449119C (225089625); 00763000743413, M442233J (225081530, 225208463); 00763000743444, M981001F (225090934); 00763000746902, BB4Q12R19 (225219615); 00763000747435, M334908K (225331456); 00763000748159, BB11A90R5 (225251333); 00763000752880, M450202U (225528160); 00763000754198, BB12A07R (225259471); 00763000760113, M337503T (225651906); 00763000760229, BB11Y04R2 (225360620); 00763000761820, M333519K (225389332); 00763000761868, BB7Q27R10 (225408607); 00763000762339, HY11V34R1 (225424991); 00763000763831, M332520A (225668319); 00763000770877, M332521A (225633224); 20643169863334, M332111B (223482422, 223815834, 224008704, 224526153, 225162263, 225651639); 20763000129440, M321634E (223631050); 20763000300085, M495227J (224865319); 20763000338477, M580440B (223422989, 223631056, 223815833, 223995015, 224225696, 224354190, 224736969, 225120477, 225528158); 20763000417677, M497549P (225049373); 20763000544526, M332710N (223538838, 223968623, 224122996, 224312703, 224526150, 225254274, 225389401); 20763000544571, M493718D (224695543); 20763000550824, M321020G (223656861); 20763000573861, M332611H (223790479, 224311663, 224567883, 225228307, 225651511); 20763000611105, M311041M (223837963, 224399255, 225162262); 20763000645599, M321634F (223952993, 224123000, 224652826, 224907241, 225209651, 225369616)

Lot Numbers:
Numbers
Product: Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.

Oxygenator Model CB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number, Tubing Pack Model Number (Lot Numbers): 00643169505322, HY2Q32R9 (223366543, 224282023); 00643169572263, HY8L55R5 (222887140, 223145744, 223145745, 223283258, 223323300, 223685612, 223685613, 223685614, 223860888, 223860889, 224043160, 224327270, 224327271, 224454137, 224623800, 224623801, 224659584, 224838251, 224838252, 224838253, 225126458); 00643169618312, HY7S51R10 (223235000, 224155208, 224454025, 224794488, 224861211); 00643169661295, HY8M65R2 (224539804); 00643169713406, HY7V67R9 (223247291, 224112023, 224752769); 00643169724310, HY8S40R2 (222974852, 223196617, 223196618, 223810224, 223810366, 224282014, 224497799, 224497800, 225047871, 225047872); 00643169771260, M530636A (223439641, 223775523, 224138283, 224695541, 225162264, 225415719); 00643169792180, M274404N (223260993, 224168527, 224567881, 224865204, 225161917); 00643169930162, HY8B05R7 (222774169, 222974885, 222974886, 223283250, 223454229, 223896471, 224112064, 224282015, 224453949, 224507422, 224659585); 00643169946392, M274204G (223311070, 223862857, 224271887, 224695322); 00643169949768, M444426D (223531132); 00643169976412, HY9M73R2 (224582508, 225251344); 00763000021252, HY6Y97R26 (223014740, 223196543, 223983908, 224154924, 224516514); 00763000050559, HY7M47R8 (223112615, 223366522, 223644448, 224454009, 224838346, 225270461); 00763000060763, M721606K (223563325, 224492621, 224652866); 00763000075866, HY9Q96R3 (222860770, 222860771, 222875738, 223066095, 223066096); 00763000077747, HY0W84R31 (223112616, 223429352, 223896872, 224414953); 00763000112042, M334821N (223352889, 223547366, 223695436, 223882113, 224164652, 224297753, 224525718, 224651356, 224780948, 225090360, 225208460, 225483418); 00763000140991, M611935D (223240763, 224008698, 224252245, 224695667, 225426642); 00763000142995, HY6Y84R14 (223014738, 223206899, 223206900, 223300938, 223323295, 223603536, 223603537, 223603538, 224327235, 224327236, 224454012, 224546574, 224685133, 224699987, 224726997, 224726999, 224727382, 224743168, 225219595, 225219596); 00763000174651, P392801C (223237110, 223392516, 223712994, 223815497, 223926243, 224033581, 224610493, 225253986); 00763000175726, HY10G12R7 (222941535, 223014639, 223258277, 223558544); 00763000187880, CB8S66R2 (222930122); 00763000197445, HY8E24R13 (222860779, 222860780, 223398133); 00763000211271, HY9R12R13 (223323289, 223685616, 224454131, 224752772, 225126466); 00763000214531, M331107A (223238102, 223482252, 223588905, 223753456, 223926779, 224168541, 224493231, 225235965); 0076300022897, M610804T (223245756, 223521603, 223815838, 223994895, 224252243, 224399667, 225120383); 00763000231491, M330808D (223393285, 223882111, 224139628, 224695324, 225303460); 00763000233259, HY5V41R21 (223112538, 223558455, 224019322, 224327283, 224664752); 00763000236588, HY7E57R17 (224019347, 224582628); 00763000236724, M720805J (224048907, 224865314); 00763000240943, HY2W45R20 (223219504); 00763000242527, HY7X65R18 (223014730, 223235005, 223685624, 223685625, 224155074, 224414984, 224794465, 225311196); 00763000245351, M495523C (223521600, 223735985, 224337085); 00763000265182, CB8J86R3 (223558410, 223895502, 224019274, 224066066, 224327165, 224539656, 224752667, 225353748); 00763000265205, CB10N15R (223558430, 223728393, 223860913, 223931078, 224019167, 224277356, 224565011); 00763000273415, HY8B75R23 (223282991, 223851410, 224454062, 224794462); 00763000275136, HY10P43R5 (223014590, 223173677, 223323145, 223454101, 224794489, 224985037); 00763000278281, M332519B (223238096, 223614706, 223909707, 224188634, 224381032, 225265095, 225561516); 00763000287948, HY9G02R4 (222774121, 223112640, 223558543, 224277436); 00763000288266, HY7W91R22 (223066105, 223323279, 223323280, 223830710, 224196553, 224370537, 224370538, 224664768); 00763000298883, CB10V63R3 (222823221, 223896439, 224112044, 224664697, 224983396); 00763000299835, HY2V10R33 (224066117, 224154914, 224327338, 224838246, 225337312); 00763000306489, HY8H57R16 (223014683, 223409297, 223853111, 224539878); 00763000316976, HY7V82R20 (222941536, 223014659, 223014660, 223283017, 223283018, 223283019, 224155220, 224243237, 224282022, 224454021, 224454022, 224659582, 224923381, 224923382, 225804403); 00763000334697, M540010F (224069885, 225024502); 00763000343347, HY11D58R1 (224794254); 00763000350642, HY10V22R6 (222917032 224154925); 00763000352288, M490123D (223862628, 224047760); 00763000353018, HY8M50R5 (223282999); 00763000356750, HY8B38R15 (222899621, 223409270, 223983893, 224794487); 00763000361426, P390012A (224123003, 224865307, 225651628); 00763000367671, HY10R64R10 (223112646, 223283254, 223603721, 223728593, 223728594, 223942689, 223942690, 224539872, 224923383); 00763000377663, HY11B96R2 (222869948, 223234995, 223764169, 223983907); 00763000378592, HY11G63R (222798773, 223014736, 223628127, 224664756, 224970824); 00763000385934, HY11H58R (222860768, 222860769, 222941490, 224897808); 00763000402495, M344705C (223268203, 223438637, 223789660, 223926249, 224271890, 225426344); 00763000404123, M431404F (223714095, 224033621, 225426912); 00763000412142, M443218G (223521614, 223926950, 224652774, 224948431, 225314012); 00763000414481, M470992C (223124424, 223310002, 223482426, 223569842, 223882106, 224297745, 224567875, 224721052, 224948433, 225208398); 00763000415495, M470265B (223261402, 223712997, 223862860, 224096970); 00763000415587, M470727H (223326985, 223837959); 00763000416645, P491704C (223665087); 00763000417659, M721808E (223311072, 223439643, 223589852, 223862854, 224252232, 224992822, 225389383); 00763000417666, M720413J (223532939, 223672422, 224297750, 224493226, 225415717, 225550859); 00763000418748, M333816C (223422902, 223695949, 223862858, 225236226, 225409827); 00763000423988, M412008A (223294764, 223378885, 223508369, 223672421, 223815829, 223994891, 224188640, 224354075, 224736966, 225161986, 225561607); 00763000424022, M496513C (223236548, 223909333); 00763000431884, M273205L (224312690, 225436686); 00763000431914, M273805F (223182875, 223352898, 223882112, 224096701, 224695311, 224865235, 225236228); 00763000432966, M310871J (223182870, 223312443); 00763000436520, M380925B (223665120); 00763000436605, M335816G (223295048, 223630919, 224077485, 224736698, 225120478); 00763000442972, HY9E87R9 (222941533, 223366512); 00763000447311, HY2S09R18 (223112596, 224154894); 00763000465834, HY10P31R19 (223065701); 00763000473884, HY6W12R19 (223234991, 223566389, 224066152, 224664755, 225311203); 00763000482039, M450473J (223167128, 223378870, 223630914, 223815843, 224008696); 00763000497842, M392419F (224168540, 224652777, 224865195, 225227363, 225409828); 00763000500955, HY11M41R1 (223282965, 224277409, 224879055); 00763000501068, HY3P08R39 (223165009, 223896457); 00763000504243, HY8E13R15 (223154600, 223851352, 224277442, 224539699); 00763000505417, HY2J36R23 (222934515, 223196717, 223498046, 223804411, 224277420, 224453965, 225219083); 00763000507404, HY9S56R16 (223066094, 223498056, 223851378, 224539869, 224923366); 00763000513047, M020506D (223246260, 223278252, 223523171, 224012635); 00763000516178, M460331G (223352894, 223569833, 223862634, 224007265, 224206452, 224610684); 00763000517854, HY9G55R5 (223569027, 223939293, 224112103, 224281970, 224414952, 224582607, 224996023); 00763000520144, HY8N22R9 (222941531, 223409269, 223939249, 224441830, 225059170); 00763000534387, HY8R65R26 (223060741, 223453845, 223645654); 00763000534561, HY6V44R36 (222860767, 223558506, 223804387, 224414937, 225045277, 225353749); 00763000535001, HY9L07R6 (223014777, 223764195, 224019358, 224327282, 224454023); 00763000535018, HY9L80R6 (223196719, 224155183); 00763000535841, HY1W12R36 (223366503, 223983898, 224370590, 225398679); 00763000538798, M444429D (223665123, 224892006); 00763000538828, M721010K (223246969, 223352905, 223507403, 223862849, 224354084); 00763000538989, M336915D (222653269, 223422024, 223569841, 224138269, 224225694, 224907238, 225345201, 225510008, 225651509); 00763000541392, M336912J (223253565, 223422901, 223776487, 224096968, 224224163, 225209650, 225389378, 225651045); 00763000542177, HY9R82R2 (223060800, 225188075); 00763000544454, HY9C49R19 (223283252, 224497859); 00763000548698, HY11N74R7 (222940914); 00763000554224, HY10H68R2 (223323276, 224497861); 00763000557188, HY4953R29 (223366546, 224281948); 00763000559663, M020517G (224033614); 00763000560348, M393040B (223439688, 223952680, 224568271, 225379258); 00763000573218, HY8X39R11 (222941588, 223234999, 223566387, 223828745, 223830706, 224019270, 224019271, 224019272, 224282105, 224414957, 224414958, 224752766, 224784929, 225008578, 225008579); 00763000574352, HY11P20R4 (222918301, 223251170, 223558439, 223983895, 224752768); 00763000574444, M611111K (223238101, 223656856, 223995006, 224441196); 00763000576752, HY11R94R1 (222849317, 222941586, 223804377, 223804378, 224282087, 224752795); 00763000578329, HY11R00R6 (222941584, 223014664, 223323292, 223323293, 223915415, 223915423, 223915425, 224327233, 224327234, 224539757, 224539758, 224963588, 225398672, 225398673); 00763000578466, HY8N78R5 (223451343, 224281999); 00763000578473, HY11M38R8 (223258276, 223498042, 224112091, 224611994); 00763000580636, HY9M86R11 (223165006, 223454161, 223942355, 224079541, 224454554, 224623802, 224838242, 225360931); 00763000580681, HY9D36R7 (223366518, 224539905); 00763000584917, M470854L (223315738, 223378935, 223569830, 223815835, 224008690, 224188632, 224525719); 00763000585655, M460236F (223315735, 223422013, 223467229, 223614713, 223881859, 224122986, 224312684); 00763000586645, M494516D (223245765, 223521606, 223776488, 224008692, 224694764, 225161912, 225346294); 00763000589769, HY11N74R10 (222982291, 223488931, 224112036); 00763000596620, P490607K (223253450, 224122988); 00763000597726, HY8J24R2 (223093362, 223409315, 224539895, 224752695); 00763000597818, M310892A (223363066, 223801585, 223952675, 224493290, 225120375, 225331164); 00763000597825, M310893A (223238090, 223521599, 224206464); 00763000600174, HY11P17R5 (223123286, 223196553, 223833439, 224277435, 224582543); 00763000602772, HY9M47R18 (223129488, 223129493); 00763000603038, M410915A (223328743, 223808306, 225463281); 00763000604301, P390707L (223439635, 223789661, 223969952, 224312696, 224694761, 225161919); 00763000606237, M460336D (223253663, 223752203, 224353778); 00763000608897, SSHY11T03R1 (223409230); 00763000611118, M496610D (223422892, 224096976, 225120482); 00763000612917, M494404C (223268763); 00763000615284, HY9M47R19 (223366472, 223366473, 223366474, 223454148, 223454149, 223454150, 224019275, 224019276, 224019277, 224053398, 224053399, 224155177, 224659580, 224699951, 224854722); 00763000616700, SSHY11U23R (223851120); 00763000618780, HY10M03R5 (223341587, 223558413, 223558414); 00763000629083, M335312B (223525625); 00763000632847, HY11V34R (223494811, 223494812, 223494813, 224453921, 224453922, 224453923, 224514485, 224516187, 224766584); 00763000636753, M333823A (223544690, 223776827); 00763000637514, HY9R33R10 (223601665, 223785673); 00763000639822, M380824C (223689373); 00763000640477, M020519A (223808288, 223815950, 223815951, 224986661, 225181585); 00763000642198, CB11V06R (223764089); 00763000643591, M491724F (224123041, 224440777, 225303506); 00763000646561, HY10P39R4 (223843622); 00763000646974, HY11W65R (224066083, 224111946, 224281897); 00763000648350, HY9E87R10 (223884685, 224497811); 00763000648374, HY11T03R2 (225317558); 00763000648909, M450473K (224297747, 224652781, 224992824, 225161913, 225346289, 225678306); 00763000648930, HY11U21R3 (223940611, 224453940, 224582538); 00763000650605, M310637D (224122625, 225415721); 00763000658632, M490123E (224252234); 00763000668211, P490607L (224289243); 00763000686307, HY11N74R11 (224277404); 00763000688158, HY2S09R20 (224623806); 00763000688844, HY11B96R3 (224301781, 225008561); 00763000690182, M337112T (225415723); 00763000700508, SSHY8M39R6 (224414826, 224453869); 00763000702021, M470734A (224465734, 225254270, 225484632); 00763000702038, M460236G (224610682, 225303511, 225484637, 225683964); 00763000704841, HY11W65R1 (224430010, 224539885, 225270470); 00763000708450, M470265C (224610324, 224694804, 224865188, 225345204, 225528223); 00763000712631, M999465A (224620478); 00763000712686, M335312D (224865285, 225389399); 00763000712716, HY10P39R5 (224681553, 225170550); 00763000715366, M470879A (224652873, 225389371); 00763000718923, M460331H (225090686, 225426909, 225651516); 00763000721381, HY11N74R12 (224714339); 00763000723521, M999464B (224735958, 225463398); 00763000723651, HY11U59R4 (224794256); 00763000733100, M312204E (224988086); 00763000733490, HY8B05R10 (224923351, 225086644, 225086645); 00763000733506, HY7X82R12 (224923357, 224923358); 00763000740184, M490123F (225219958); 00763000740245, HY8E13R17 (225008507, 225353751); 00763000740948, HY11M38R12 (225059160); 00763000743079, M311707F (225173692); 00763000744922, P491620A (225331247); 00763000746797, HY8B75R30 (225408619); 00763000762339, HY11V34R1 (225699280, 225699281); 00763000763121, M470879B (225667573); 00763000764753, M470992D (225615056, 225728238); 20763000300085, M495227J (223261403, 223508312, 224381029, 225474132); 20763000417677, M497549P (223294754, 223422988, 223508366, 223713001, 224122614, 224652867, 225254288, 225484791); 20763000544571, M493718D (223238293, 223378938, 223714097, 224008807, 224337421, 225120475); 20763000661117, M494407A (224170341, 225447056);

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91343
Status: Active
Manufacturer: Medtronic Perfusion Systems
Manufactured In: United States
Units Affected: 6 products (2,937 units; 90,220 units; 1,340 units; 4,462 units; 63,278 units; 40,498 units)
Agency Last Updated: March 13, 2023

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.