FDA Device recall Z-1117-2013
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere elec…
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere elec… by Hospira, citing during infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1117-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-21 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hospira |
| Distribution | US |
Product
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 by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
Reason
During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Identifiers
| code_info | List Numbers: 13086, 13087, 13088 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1117-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.