U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
데이터 추가 비고
Pump, Infusion - Product Code FRN
원인
During infusions of 2.0 ml/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
조치
Hospira sent an Urgent Device Field Correction letter dated March 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to refrain from using the affected produc and contact Hospira at 1-800-441-4100 to arrange for return of their device for repair. Customers were directed to notify their customers if they further distributed the product and confirm they have done so by return of the reply form to Stericycle.
For questions regarding this recall call 224-212-4892.
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.
제품 설명
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.