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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 Recall
GemStar Infusion System
see related information
Date Posted April 15, 2013
Recall Status1 Open
Recall Number Z-1117-2013
Recall Event ID 64841
Premarket Notification
510(K) Numbers
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: 13086, 13087, 13088
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 13086: 286 pumps; 3) List Number 13087: 45,376 pumps; 4) List Number 13088: 23,492 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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