Medtronic Perfusion Systems: Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. 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: 63,278 units Lot/code info: 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); 00

UPC codes

00643169231948, 00643169345379, 00643169422025, 00643169439269, 00643169449442, 00643169469495, 00643169572263, 00643169583542, 00643169621473, 00643169622715, 00643169632097, 00643169639027, 00643169645424, 00643169674486, 00643169692893, 00643169711945, 00643169717336, 00643169750883, 00643169793699, 00643169793927, 00643169840058, 00643169860643, 00643169865365, 00643169872127, 00643169876743, 00643169876903, 00643169955790, 00643169957008, 00643169998643, 00763000006884, 00763000008215, 00763000014001, 00763000014971, 00763000016944, 00763000021887, 00763000024406, 00763000025878, 00763000026240, 00763000062613, 00763000062637

Source

Official record: FDA (Device enforcement) ↗

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