Device recall
Z-1310-2023: Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set…
FDA device recall · Class II · Iradimed Corporation
Key facts
| Recall number (Z-number) | Z-1310-2023 |
|---|---|
| Recall event | 91846 |
| Product | Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50, |
| Product code | FRN |
| Recalling firm | Iradimed Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K050301, K090087, K143369 |
| FEI number | 3005053560 |
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