Recall Z-0456-2022 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Nikkiso Ltd - Shizuoka Plant
DBB-06 Hemodialysis Delivery System
| Date | Nov 24, 2021 |
| Status | Open, Classified |
| Reason | Device lacks premarket approval. |
| 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 CS@nikkisomedical.us |
| Quantity | 781 units |
| Distribution | Distributed nationwide to NY, MO, WA, CA, and TN. |
| FDA record | Open on fda.gov |