FDA Device recall Z-0456-2022
DBB-06 Hemodialysis Delivery System
- FDA Device
- Class II
- ongoing
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class II recall of DBB-06 Hemodialysis Delivery System by Nikkiso Shizuoka Plant, citing device lacks premarket approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0456-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-24 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nikkiso Shizuoka Plant |
| Distribution | US |
Product
DBB-06 Hemodialysis Delivery System
Reason
Device lacks premarket approval.
Identifiers
| code_info | Model Number: DBB-06; Serial Numbers: J1910861, J1905670, J1905916, J1910971, J1909943, J1909306, J1908111, J1909202, J…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, J1 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0456-2022%22
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