Summary
The FDA issued a Class II for DBB-06 Hemodialysis Delivery System by Nikkiso Ltd - Shizuoka Plant. Reason: Device lacks premarket approval..
Details
Source
Device Recall
External ID
Z-0456-2022
Action Date
2022-01-12
Status
Ongoing
Category
device
Product Description
DBB-06 Hemodialysis Delivery System
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
Quantity Affected: 781 units
Reason for Recall
Device lacks premarket approval.
Distribution
Distributed nationwide to NY, MO, WA, CA, and TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-24
Company
Makinohara, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nikkiso Ltd - Shizuoka Plant) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nikkiso Ltd - Shizuoka Plant have FDA actions?
This is the only FDA action we have on record for Nikkiso Ltd - Shizuoka Plant in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0456-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29