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

Hazard

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.

Details from the source

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: 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, Hond Quantity: 90,220 units Lot/code info: 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, 224772

UPC codes

00643169354869, 00643169354883, 00643169588660

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.