Z-1028-2023 Class II Ongoing

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

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.

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);