Device recall
Z-1228-2026: PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or…
FDA device recall · Class II · VANTIVE US HEALTHCARE LLC
Key facts
| Recall number (Z-number) | Z-1228-2026 |
|---|---|
| Recall event | 98180 |
| Product | PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Product code | KDI |
| Recalling firm | VANTIVE US HEALTHCARE LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K080519 |
| FEI number | 3038195011 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database