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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91343

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 12, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Perfusion Systems

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

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

Z-1023-2023
Recall number
Z-1023-2023
Initiated
December 12, 2022
Classification
Class II
Status
Ongoing
Quantity
2,937 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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)

Distribution pattern

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.

device · product 2 of 6

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

Z-1024-2023
Recall number
Z-1024-2023
Initiated
December 12, 2022
Classification
Class II
Status
Ongoing
Quantity
90,220 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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)

Distribution pattern

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.

device · product 3 of 6

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

Z-1025-2023
Recall number
Z-1025-2023
Initiated
December 12, 2022
Classification
Class II
Status
Ongoing
Quantity
1,340 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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)

Distribution pattern

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.

device · product 4 of 6

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

Z-1026-2023
Recall number
Z-1026-2023
Initiated
December 12, 2022
Classification
Class II
Status
Ongoing
Quantity
4,462 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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)

Distribution pattern

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.

device · product 5 of 6

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

Z-1027-2023
Recall number
Z-1027-2023
Initiated
December 12, 2022
Classification
Class II
Status
Ongoing
Quantity
63,278 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

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.

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)

Distribution pattern

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.

device · product 6 of 6

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

Z-1028-2023
Recall number
Z-1028-2023
Initiated
December 12, 2022
Classification
Class II
Status
Ongoing
Quantity
40,498 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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);

Distribution pattern

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.