Z-1024-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2023
- Initiation Date
- December 12, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90,220 units
Product Description
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
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.
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.
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)