Device recall
Z-1255-2023: Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural…
FDA device recall · Class II · Fenwal Inc
Key facts
| Recall number (Z-number) | Z-1255-2023 |
|---|---|
| Recall event | 91704 |
| Product | Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform |
| Product code | LKN |
| Recalling firm | Fenwal Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K180615 |
| FEI number | 3004548776 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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