Skip to content
Recall Observatory FDA recall evidence

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-1170-2013

March 18, 2013

Class I

Product summary

Firm
Hospira Inc.
Event
Event 64837
Status
Terminated
Classification
Class I
Quantity
List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,942 pumps
Official record key
device-enforcement:Z-1170-2013

Official wording

Reason: Pump shutting off during use without warning.

Code information: List Numbers: 13086, 13087, 13088

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

    reason.no_named_rule · v1.0.0

    Pump shutting off during use without warning.