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U.S. Department of Health and Human Services

Class 2 Device Recall GemStar Infusion System

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  Class 2 Device Recall GemStar Infusion System see related information
Date Initiated by Firm March 21, 2013
Date Posted April 15, 2013
Recall Status1 Open3, Classified
Recall Number Z-1116-2013
Recall Event ID 64841
510(K)Number K060806  K083019  
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.
Code Information List Numbers: 13000, 13100, 13150
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information Contact Chris Eustace
224-212-4892
Manufacturer Reason
for Recall
During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
FDA Determined
Cause 2
Nonconforming Material/Component
Action 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.
Quantity in Commerce 1) List Number 13000: 25,119 pumps; 2) List Number 13100: 185 pumps; 3) 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.
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