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.
Reported: April 24, 2013 Initiated: March 21, 2013 #Z-1116-2013
Product Description
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 for Recall
During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 1) List Number 13000: 25,119 pumps; 2) List Number 13100: 185 pumps; 3) List Number 13150: 13,497 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, 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.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hospira Inc.. Units affected: 1) List Number 13000: 25,119 pumps; 2) List Number 13100: 185 pumps; 3) List Number 13150: 13,497 pumps.
Why was this product recalled? ▼
During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2013. Severity: Moderate. Recall number: Z-1116-2013.
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