Z-0456-2022Class II

DBB-06 Hemodialysis Delivery System

Name: Z-0456-2022 DBB-06 Hemodialysis Delivery System
Creator: Nikkiso Ltd - Shizuoka Plant
Published: 2021-11-24
License: https://open.fda.gov/license/

Nikkiso Co., Ltd. - Shizuoka Plant / initiated 2021-11-24 / Open, Classified

FDA source

Nikkiso Ltd - Shizuoka Plant began a recall of DBB-06 Hemodialysis Delivery System on 2021-11-24. FDA classified it as Class II and gives the reason as "Device lacks premarket approval". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0456-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-24
Posted: 2022-01-05
Recalling firm: Nikkiso Co., Ltd. - Shizuoka Plant
Product: DBB-06 Hemodialysis Delivery System
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: Device lacks premarket approval.
FDA root cause: Under Investigation by firm
Action: 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 [email protected]
Quantity in commerce: 781 units
Distribution: Distributed nationwide to NY, MO, WA, CA, and TN.
Product codes and lots: 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, 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0456-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0456-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-12	2022-01-05

Product code KDI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)