Device recall
Z-1999-2011: GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application…
FDA device recall · Class II · Hospira Inc.
Key facts
| Recall number (Z-number) | Z-1999-2011 |
|---|---|
| Recall event | 58202 |
| Product | GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira, Inc., Lake Forest, IL 60045; list 13092-04-01 A stand-alone PC application for administration of medications specific to the GemStar Infuser |
| Product code | FRN |
| Recalling firm | Hospira Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 29, 2016 |
| 510(k) numbers | K083019 |
| 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