DBB-06 Hemodialysis Delivery System recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number: DBB-06; Serial Numbers: J1910861, J1905670, J1905916, J1910971, J1909943, J1909306, J1908111, J1909202, J1907127, J1908023, J1910962, J1910866, J1910028, J1909307, J1907329, J1909853, J1908776, J1908108, J1914585, J1908762, J1909020, J1908872, J1908439, J1908777, J1910867, J1911026, J1907034, J1911033, J1908665, J1909209, J1909705, J1906923, J1911029, J1910870, J1910967, J1911040, J1910499, J1905788, J1910558, J1909689, J1910498, J1909315, J1909662, J1906052, J1910692, J1909412, J1908116, J1910688, J1908582, J1908657, J1909017, J1908281, J1908581, J1909012, J1908660, J1907321, J1907123, J1907317, J1911036, J1905580, J1911354, J1911217, J1907939, J1911035, J1908584, J1911039, J1906050, J1910494, J1909850, J1910560, J1908020, J1908115, J1907932, J1908118, J1910774, J1905789, J1905576, J1909116, J1910489, J1909312, J1908435, J1905791, J1905921, J1910116, J1910027, J1909407, J1909406, J1910491, J1909405, J1909952, J1910495, J1910023, J1909947, J1909945, J1909690, J1910296, J1910300, J1910112, J1910030, J1909414, J1909308, J1909942, J1909313, J1910118, J1905793, J1910690, J1905920, J1910686, J1910400, J1911038, J1910297, J1910115, J1910406, J1905927, J1910136, J1908417, J1908778, J1908034, J1907320, J1909122, J1908114, J1907116, J1908664, J1906921, J1908112, J1908870, J1908757, J1908120, J1908570, J1908291, J1907937, J1908441, J1908583, J1908658, J1908024, J1909022, J1908030, J1908770, J1909204, J1908285, J1907931, J1910862, J1908866, J1908426, J1908774, J1908033, J1908113, J1908750, J1906826, J1907119, J1909021, J1907122, J1908773, J1908659, J1908771, J1909200, J1909199, J1908779, J1909011, J1908571, J1909117, J1906927, J1910860, J1911223, J1911352, J1905787, J1905926, J1910969, J1909708, J1905799, J1911220, J1910562, J1910864, J1908025, J1907926, J1909109, J1909119, J1908751, J1908412, J1907106, J1909024, J1907033, J1908662, J1911115, J1914588, J1911222, J1905800, J1910857, J1910488, J1905795, J1905919, J1908752, J1910402, J1914584, J1905667, J1910869, J1908424, J1905918, J1905575, J1905798, J1908760, J1905579, J1910685, J1910691, J1911114, J1905923, J1908572, J1905922, J1905578, J1905581, J1905928, J1911027, J1911216, J1905584, J1911221, J1905666, J1911218, J1910868, J1905660, J1905582, J1905674, J1910687, J1908022, J1909208, J1909120, J1908107, J1910856, J1910779, J1910564, J1910863, J1905577, J1905930, J1909110, J1905801, J1908109, J1908768, J1911219, J1910694, J1906055, J1908772, J1914587, J1906053, J1911357, J1909304, J1908871, J1908663, J1908289, J1907126, J1908661, J1908294, J1908575, J1908769, J1905668, J1909305, J1909196, J1908578, J1909197, J1909195, J1908754, J1908117, J1909015, J1908026, J1909013, J1907105, J1906825, J1909112, J1908758, J1909206, J1910563, J1910775, J1909121, J1909203, J1907453, J1909111, J1907328, J1908867, J1908414, J1908775, J1911350, J1908761, J1909114, J1907928, J1907933, J1908416, J1908428, J1908437, J1908865, J1909019, J1909123, J1906926, J1907936, J1908749, J1908763, J1909115, J1909118, J1908110, J1908421, J1908580, J1908874, J1909207, J1908579, J1909302, J1908415, J1908873, J1907109, J1907318, J1907454, J1907927, J1907929, J1908021, J1908119, J1908280, J1908282, J1908423, J1908429, J1908442, J1908577, J1908651, J1908753, J1908759, J1909010, J1907128, J1907935, J1908031, J1908780, J1909014, J1906827, J1906830, J1907930, J1906829, J1906924, J1906925, J1906930, J1907029, J1907035, J1907037, J1907315, J1907324, J1907925, J1907938, J1908027, J1908028, J1908029, J1908032, J1908290, J1908419, J1908420, J1908430, J1908433, J1908436, J1908438, J1908440, J1908574, J1908576, J1908655, J1908781, J1908868, J1909016, J1909018, J1909023, J1909113, J1909198, J1906831, J1906834, J1907038, J1907117, J1907118, J1907124, J1908283, J1908284, J1908286, J1908413, J1908425, J1908432, J1908434, J1908652, J1908869, J1907125, J1908293, J1908418, J1908431, J1908573, J1908654, J1907326, J1908422, J1908653, J1907120, J1907325, J1908292, J1906838, J1906118, J1906400, J1906784, J1906824, J1906828, J1906835, J1906836, J1906928, J1906108, J1906121, J1906291, J1906404, J1906779, J1906780, J1906781, J1906782, J1906110, J1906113, J1906832, J1906931, J1906932, J1906933, J1906411, J1906109, J1906117, J1906282, J1906287, J1906405, J1906407, J1906409, J1906281, J1906286, J1906289, J1906292, J1906293, J1906294, J1906408, J1906116, J1906280, J1906283, J1906403, J1906783, J1907114, J1906929, J1907031, J1907032, J1907036, J1907115, J1907455, J1906833, J1906920, J1906934, J1907108, J1907322, J1907323, J1906107, J1906837, J1906922, J1907030, J1907121, J1907319, J1906778, J1906511, J1906663, J1906664, J1906667, J1906668, J1906669, J1906671, J1906672, J1906673, J1906675, J1906677, J1907458, J1907459, J1907460, J1907463, J1907464, J1907465, J1907466, J1907624, J1907625, J1907628, J1907630, J1907631, J1907633, J1907636, J1907637, J1907711, J1907712, J1907713, J1907714, J1907715, J1907716, J1907717, J1907719, J1907720, J1907722, J1907723, J1906410, J1906509, J1906510, J1906666, J1906670, J1906674, J1906770, J1907456, J1907457, J1907461, J1907627, J1907629, J1907632, J1907634, J1907635, J1907718, J1907725, J1906120, J1906676, J1906774, J1907462, J1907467, J1907626, J1907638, J1907721, J1907724, J1906773, J1906401, J1906499, J1906506, J1906507, J1906111, J1906115, J1906285, J1906402, J1906406, J1906498, J1906500, J1906501, J1906503, J1906290, J1906413, J1906497, J1906502, J1906505, J1906114, J1906119, J1906504, J1906772, J1906775, J1906776, J1906412, J1906665, J1906771, J1906777, J1906112, J1612940, J1707101, J1707103, J1707109, J1707138, J1704039, J1707116, J1707127, J1707129, J1707139, J1707145, J1707130, J1707137, J1707120, J1707111, J1707118, J1707119, J1707124, J1707125, J1707126, J1707134, J1707104, J1613227, J1707105, J1707106, J1707131, J1707140, J1707141, J1707117, J1707136, J1707144, J1707110, J1707121, J1707123, J1707128, J1707132, J1707135, J1702725, J1707115, J1707122, J1707143, J1708043, J1702641, J1707102, J1707142, J1702650, J1707107, J1707113, J1708033, J1708063, J1708069, J1707114, J1708044, J1708047, J1708049, J1708058, J1708066, J1707112, J1708035, J1708042, J1708060, J1707133, J1708056, J1608042, J1613054, J1612948, J1708046, J1708051, J1708059, J1708064, J1708067, J1708031, J1708054, J1708036, J1708038, J1708048, J1708055, J1708062, J1708032, J1708045, J1708065, J1703829, J1703837, J1704035, J1704046, J1704051, J1704052, J1708037, J1708041, J1708052, J1708061, J1708057, J1703831, J1703841, J1708053, J1703827, J1703840, J1708034, J1708039, J1708040, J1708068, J1702722, J1703828, J1703830, J1703833, J1703834, J1703836, J1703838, J1703839, J1703842, J1703843, J1703845, J1703846, J1704036, J1704037, J1704038, J1704041, J1704044, J1704045, J1704047, J1704048, J1704049, J1704050, J1704053, J1704054, J1704055, J1704056, J1612943, J1613043, J1613241, J1704043, J1702716, J1702727, J1612942, J1702637, J1702649, J1702711, J1613046, J1702715, J1702731, J1703844, J1702714, J1613044, J1702631, J1613036, J1702712, J1702718, J1613035, J1702632, J1702642, J1612947, J1702635, J1702726, J1613236, J1702634, J1702713, J1702717, J1702724, J1702728, J1702633, J1702639, J1702647, J1702723, J1702729, J1702730, J1703832, J1704042, J1702648, J1704040, J1612931, J1612932, J1612937, J1612939, J1612941, J1613042, J1613045, J1613048, J1612946, J1612930, J1612936, J1612944, J1613053, J1613051, J1613039, J1613040, J1613049, J1612934, J1613038, J1612938, J1613041, J1609143, J1609144, J1609145, J1609146, J1609147, J1609148, J1609149, J1609137, J1609138, J1609139, J1609140, J1609141, J1609142, J1612935, J1613037, J1613047, J1612945, J1613050, J1613052, J1609033, J1609034, J1609134, J1609135, J1609136, J1608930, J1608940, J1608947, J1609031, J1609032, J1609036, J1609132, J1609133, J1609027, J1609028, J1609029, J1609035, J1608943, J1608946, J1608941, J1608942, J1608944, J1608945, J1608938, J1608939, J1608040, J1608041

Product

DBB-06 Hemodialysis Delivery System

Recalling firm

Nikkiso Ltd - Shizuoka Plant

Quantity

781 units

Distribution

Distributed nationwide to NY, MO, WA, CA, and TN.

Recall date

January 12, 2022

Classification

Class II

Status

Ongoing

Agency

FDA (device)