Device 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. 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.
Z-1169-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 64837
- Status
- Terminated
- Classification
- Class I
- Quantity
- List Number 13000: 25,119 pumps; List Number 13100: 185 pumps; List Number 13150: 13,497 pumps
- Official record key
device-enforcement:Z-1169-2013
Official wording
Reason: Pump shutting off during use without warning.
Code information: List Numbers: 13000, 13100, 13150
Distribution pattern: 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.
Derived failure modes
-
Unknown
Pump shutting off during use without warning.