Nikkiso Ltd – Shizuoka Plant Recall 88641
Description: DBB-06 Hemodialysis Delivery System
Nikkiso Ltd – Shizuoka Plant Recall 88641 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0456-2022 |
| Event ID | 88641 |
| Event Description | DBB-06 Hemodialysis Delivery System |
| Product Type | Devices |
| Distribution | Distributed nationwide to NY, MO, WA, CA, and TN. |
| Quantity | 781 units |
| Recall Reason | Device lacks premarket approval. |
| Device Classification | 20220112 |
| Device 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, 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| Center Classification Date | 20220105 |
| Recall Initiation Date | 20211124 |
| Recalling Firm | Nikkiso Ltd - Shizuoka Plant |
| Initial Notification | Letter |
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