Device recall
Z-0831-2025: nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163…
FDA device recall · Class I · Nuwellis Inc
Key facts
| Recall number (Z-number) | Z-0831-2025 |
|---|---|
| Recall event | 95991 |
| Product | nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System |
| Product code | KDI |
| Recalling firm | Nuwellis Inc |
| Recall class | Class I |
| Status | Completed |
| 510(k) numbers | K192756 |
| FEI number | 3007137787 |
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