Use caution Medical device recall · FDA · Published December 12, 2022
Medtronic Perfusion Tubing Packs with Loose Temperature Monitoring Adapter Risk
Recall of Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance due to Temperature Monitoring Adapter coming loose during setup or disassembly, potentially causing complications during cardiopulmonary bypass procedures.
Use caution until it’s fixed
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.
Contact the company
Recalling firmMedtronic Perfusion Systems7611 Northland Dr N · Brooklyn Park, MN 55428-1088
What happened, in plain English
Medtronic is recalling Custom Pack Perfusion Tubing Packs with Affinity Fusion Oxygenators that have a Temperature Monitoring Adapter (TMA) which may become loose during setup or after disassembly. This could lead to improper temperature monitoring during cardiopulmonary bypass procedures, risking complications for patients. Read more at govinfonow.com/recall/59160-medtronic-perfusion-tubing-packs-with-loose-temperature-monitoring-adapter-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/59160-medtronic-perfusion-tubing-packs-with-loose-temperature-monitoring-adapter-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1028-2023
Cite this page
“Medtronic Perfusion Tubing Packs with Loose Temperature Monitoring Adapter Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59160-medtronic-perfusion-tubing-packs-with-loose-temperature-monitoring-adapter-risk. Based on FDA recall #Z-1028-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1028-2023%22&limit=1).
Why it’s dangerous
The Temperature Monitoring Adapter (TMA) on the Affinity Fusion Oxygenator can become loose during pre-procedure setup or post-procedure disassembly. This may cause improper temperature monitoring during cardiopulmonary bypass procedures, potentially leading to complications for patients.
Who’s affected
Patients undergoing cardiopulmonary bypass surgery using the recalled tubing packs are most at risk. Healthcare providers using these specific models for surgical procedures may also be affected.
How to tell if you have this one
Check for Custom Pack Perfusion Tubing Packs with Affinity Fusion Oxygenator model CB811, serial numbers between 8111483548 and 8113999999, or specific GTIN numbers and lot numbers listed in the recall notice.
- Brand
Medtronic Perfusion Systems- Category
Medical device
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1023-2023 | 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) | 2,937 units |
| Z-1024-2023 | 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) | 90,220 units |
| Z-1025-2023 | 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) | 1,340 units |
| Z-1026-2023 | 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) | 4,462 units |
| Z-1027-2023 | 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) | 63,278 units |
| Z-1028-2023 | 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); | 40,498 units |
What to do — step by step
Check for Loose Temperature Monitoring Adapter
Inspect the Temperature Monitoring Adapter (TMA) on the Affinity Fusion Oxygenator to ensure it is securely attached during setup and disassembly.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 58 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1028-2023 (December 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1028-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.