DBB-06 Hemodialysis Delivery System
This recall is currently active, issued November 24, 2021. It was issued by Nikkiso Ltd Shizuoka Plant 498 1 Shizutani; Shizuoka-Ken Makinohara Japan.
- Recall Initiated
- November 24, 2021
- Recall Number
- Z-0456-2022
- Quantity
- 781 units
- Official Source
- View on FDA website ↗
Reason for Recall
Device lacks premarket approval.
Distribution
Distributed nationwide to NY, MO, WA, CA, and TN.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
Nikkiso notified customers on about 11/24/2021, via letter titled MEDICAL DEVICE RECALL. Customers were instructed that the affected functions have been disabled on affected units and no actions need to be taken. Customers were asked to complete the provided response form and return it to the technical service when they visit each facility to complete the software update. Questions can be directed to the firm at at 901-310-1567 option 1, Monday Friday, 9:00am-5:00pm CST, or by email at CS@nikkisomedical.us