Drug recall
MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT…
FDA recall event 81808 · Class II · Bayer Medical Care, Inc.
Key facts
| Event ID | 81808 |
|---|---|
| Recall numbers | Z-0745-2019 |
| Recalling firm | Bayer Medical Care, Inc. |
| Product type | Devices |
| Products | MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall. |
| Initiation date | Dec 14, 2018 |
| Report date | Jan 23, 2019 |
| Termination date | Jun 16, 2020 |
| 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: