Recall Z-1170-2013 ยท FRN Pump, Infusion
Hospira Inc.
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. The GemStar Pum
| Date | Apr 30, 2013 (initiated Mar 18, 2013) |
| Status | Terminated |
| Reason | Pump shutting off during use without warning. |
| Root cause | Device Design |
| Action | Hospira sent an Important Device Information letter dated March 18, 2013, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect the affected product for signs of leakage, corrosion or other damage prior to each use. In addition, each time the batteries are replaced the battery compartment should be inspected for damage. If a device exhibits damage caused by leakage, it should immediately be removed from clinical service and Hospira should be contacted at 1-800-441-4100 to arrange for return |
| Quantity | List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,942 pumps |
| Distribution | Worldwide Distribution - USA (nationwide) and internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083019 | GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE Hospira, Inc., Oct 22, 2008 |