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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 016 04 13 000
Date submitted: 4/3/2013
Manufacturer:Hospira Inc
Device Type:Infusion, GemStar Infusion Pumps
Description:Infusion Pumps
Medical Device Identifier:List Number: 13000,13100,13150,13086,13087,13088 Affected Units: All GemStar Infusion Pumps
Reason of Field Safety Corrective Action:voltage of the lithium battery dropping below 2.4 volts.
Remedy Action:lithium batteries that are older than five (5) years should be replaced. Contact your local Hospira office to determine if your battery needs to be replaced and, if necessary to arrange for the return of your device to perform battery replacement. Modification will be made to the GemStar Technical Service Manual (TSM) to indicate that the useful life of the lithium Battery is five (5) years.
Athorized Representative/Importer/Distributor:AL-KAMAL Import, Riyadh, (01) 2181122
Report Source:NCMDR
Source Ref. Number:809D8BCEC1337
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Hospira Inc.pdf