Drug recall
PET Infusion Pump
FDA recall event 75387 · Class II · Bayer Healthcare
Key facts
| Event ID | 75387 |
|---|---|
| Recall numbers | Z-0400-2017 |
| Recalling firm | Bayer Healthcare |
| Product type | Devices |
| Products | PET Infusion Pump |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past… |
| Initiation date | Sep 30, 2016 |
| Report date | Nov 23, 2016 |
| Termination date | Mar 24, 2017 |
| 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: