Device recall
Z-1523-2013: AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS…
FDA device recall · Class II · Fenwal Inc
Key facts
| Recall number (Z-number) | Z-1523-2013 |
|---|---|
| Recall event | 65296 |
| Product | AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path. |
| Product code | LKN |
| Recalling firm | Fenwal Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 1, 2016 |
| 510(k) numbers | K111702 |
| 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