Device recall
Z-0359-2017: Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette…
FDA device recall · Class II · Unomedical As
Key facts
| Recall number (Z-number) | Z-0359-2017 |
|---|---|
| Recall event | 74242 |
| Product | Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for… |
| Product code | FPA |
| Recalling firm | Unomedical As |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 16, 2016 |
| 510(k) numbers | K002138 |
| FEI number | 1000477110 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 1,000+ 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