Drug recall
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in…
FDA recall event 64841 · Class II · Hospira Inc.
Key facts
| Event ID | 64841 |
|---|---|
| Recall numbers | Z-1116-2013, Z-1117-2013 |
| Recalling firm | Hospira Inc. |
| Product type | Devices |
| Products | The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion. |
| Initiation date | Mar 21, 2013 |
| Report date | Apr 24, 2013 |
| Termination date | Aug 29, 2016 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3005579246 |
At a glance
- 1–9 Products in this recall
- None 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: