Drug recall
Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable…
FDA recall event 74513 · Class II · Bayer Healthcare
Key facts
| Event ID | 74513 |
|---|---|
| Recall numbers | Z-2244-2016 |
| Recalling firm | Bayer Healthcare |
| Product type | Devices |
| Products | Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner. |
| Initiation date | Jun 9, 2016 |
| Report date | Jul 27, 2016 |
| Termination date | Dec 5, 2016 |
| City | Indianola |
| State | PA |
| Country | United States |
| FEI number | 2520313 |
At a glance
- 1–9 Products in this recall
- 10–99 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: