|
Class 2 Device Recall Affinity Fusion Oxygenator |
|
Date Initiated by Firm |
December 12, 2022 |
Date Posted |
January 27, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1027-2023 |
Recall Event ID |
91343 |
510(K)Number |
K203111
|
Product Classification |
Oxygenator, cardiopulmonary bypass - Product Code DTZ
|
Product |
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass. |
Code Information |
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) |
Recalling Firm/ Manufacturer |
Medtronic Perfusion Systems 7611 Northland Dr N Brooklyn Park MN 55428-1088
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For Additional Information Contact |
Medtronic Customer Service 800-854-3570
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Manufacturer Reason for Recall |
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.
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FDA Determined Cause 2 |
Process change control |
Action |
Medtronic initially notified consignees on 12/12/2022 and followed up with an updated notification on 12/21/2022. Consignees were advised of two options: 1. Continue to use the Affinity Fusion Oxygenator without using the TMA (use other conventional perfusion circuit temperature monitoring methods); or 2. Continue to use the Affinity Fusion Oxygenator and the TMA for arterial temperature monitoring. Ensure there is minimal torque applied to the oxygenator TMA when attaching or detaching the Temperature Probe (Product Number ATP210). Also, minimize manipulation of the TMA-probe connection during the clinical procedure. Consignees were also advised to complete and return the Customer Confirmation Form, and notify personnel or facilities were affected units are located.
On about 02/10/2023, Medtronic initiated an expansion and notified customers. Instructions in the customer letter remained the same. |
Quantity in Commerce |
63,278 units |
Distribution |
Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Ethiopia, Finland, France, Germany, Ghana, Greece, Guatemala, Honduras, Hungary, Iceland, Indonesia, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lithuania, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Nigeria, North Macedonia, Norway, Oman, Pakistan, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, Turkmenistan, Uganda, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, and Yemen.
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = DTZ and Original Applicant = Medtronic
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