FDA Recall
Open, Classified
DBB-06 Hemodialysis Delivery System
Recall: Z-0456-2022
·
Initiated November 24, 2021
Recall
- Recall Number
- Z-0456-2022
- Event Number
- 88641
- Firm
- Nikkiso Ltd Shizuoka Plant 498 1 Shizutani; Shizuoka-Ken Makinohara Japan
- FEI Number
- 3002807721
- Product Code
- KDI
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- November 24, 2021
Description
DBB-06 Hemodialysis Delivery System
Reason
Device lacks premarket approval.
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]
Distribution
Distributed nationwide to NY, MO, WA, CA, and TN.
Quantity
781 units