Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

DBB-06 Hemodialysis Delivery System

FDA Recall Z-0456-2022 · Posted None

Recalling FirmNikkiso Ltd - Shizuoka Plant
Recall StatusOpen, Classified
Product CodeKDI
Date Initiated2021-11-24
Product Quantity781 units

Reason for Recall

Device lacks premarket approval.

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]

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed nationwide to NY, MO, WA, CA, and TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152938DBB-06 Hemodialysis Delivery SystemNIKKISO CO., LTD. · 2016-03-18K091978DBB-06 HEMODIALYSIS DELIVERY SYSTEMNIKKISO CO., LTD. · 2010-03-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑