Device recall
Z-0342-2025: Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use…
FDA device recall · Class II · The Metrix Company
Key facts
| Recall number (Z-number) | Z-0342-2025 |
|---|---|
| Recall event | 95499 |
| Product | Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration. |
| Product code | KPE |
| Recalling firm | The Metrix Company |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K030888 |
| FEI number | 1000117446 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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