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

Recalled May 8, 2013 · FDA recall Z-1159-2013 · 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 13000: 25,119 pumps; List Number 13100: 185 pumps; List Number 13150: 13,497 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 →