Device recall
Z-0446-2013: The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV…
FDA device recall · Class II · Iradimed Corporation
Key facts
| Recall number (Z-number) | Z-0446-2013 |
|---|---|
| Recall event | 63675 |
| Product | The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, do not resterilize, and is… |
| Product code | FRN |
| Recalling firm | Iradimed Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 19, 2013 |
| 510(k) numbers | K050301 |
| 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