RecallWatchUSA

Home / Recalls / Medical Devices

Hospira Inc. recalls GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device d

Recalled May 8, 2013 · FDA recall Z-1160-2013 · Hospira

Hazard
Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used. · FDA Class I
Units
List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,492 pumps
Sold at
Worldwide Distribution - USA (nationwide) 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, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.

Description

Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.

Product
GemStar Pump - Battery Product Usage: 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.
Manufacturer(s)
Hospira Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Hospira Inc. recalls GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device d | RecallWatchUSA