Device recall
Z-0421-2015: GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain…
FDA device recall · Class II · Hospira Inc.
Key facts
| Recall number (Z-number) | Z-0421-2015 |
|---|---|
| Recall event | 69505 |
| Product | GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional… |
| Product code | FRN |
| Recalling firm | Hospira Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 9, 2016 |
| 510(k) numbers | K060806 |
| FEI number | 3013319212 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database