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U.S. Department of Health and Human Services

Class 1 Device Recall GemStar Infusion System

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 Class 1 Recall
GemStar Infusion System
see related information
Date Posted April 30, 2013
Recall Status1 Open
Recall Number Z-1169-2013
Recall Event ID 64837
Premarket Notification
510(K) Number
K060806 
Product Classification Pump, Infusion - Product Code FRN
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.
Code Information List Numbers: 13000, 13100, 13150
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. Chris Eustace
224-212-4892
Manufacturer Reason
for Recall
Pump shutting off during use without warning.
FDA Determined
Cause 2
DESIGN: Device Design
Action Hospira sent an Important Device Information letter dated March 18, 2013, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect the affected product for signs of leakage, corrosion or other damage prior to each use. In addition, each time the batteries are replaced the battery compartment should be inspected for damage. If a device exhibits damage caused by leakage, it should immediately be removed from clinical service and Hospira should be contacted at 1-800-441-4100 to arrange for return of the device for repair. If the product has been further distributed they should notify their consignees and confirm they have done so by returning the reply form to Stericycle. For questions regarding this recall call 224-212-4892.
Quantity in Commerce List Number 13000: 25,119 pumps; List Number 13100: 185 pumps; 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.
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