FDA-Device2014-06-11Class II
LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
Hospira Inc.
Hazard
There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion
Sold states
Worldwide Distribution - USA nationwide including District of Columbia, Puerto Rico, and US Virgin Islands; Australia, Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Jordan, Kuwait, Luxembourg, Mexico, Oman, Peru, Poland, Portugal, Qatar, Russia, San Marino, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Yemen.
Affected count
List Number 02507: 132,889 pumps
Manufactured in
275 N Field Dr, Lake Forest, IL, United States
Products
LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1702-2014Don't want to check this manually?
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