Drug recall
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF…
FDA recall event 91846 · Class II · Iradimed Corporation
Key facts
| Event ID | 91846 |
|---|---|
| Recall numbers | Z-1310-2023 |
| Recalling firm | Iradimed Corporation |
| Product type | Devices |
| Products | Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50, |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe… |
| Initiation date | Feb 24, 2023 |
| Report date | Apr 5, 2023 |
| City | Winter Springs |
| State | FL |
| Country | United States |
| FEI number | 3005053560 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: