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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 122 03 15 000
Date submitted: 3/30/2015
Manufacturer:US Endoscopy
Device Type:Talon® grasping device
Description:Grasping device
Medical Device Identifier:Model Number: 00711175
Affected Lot Numbers:
1407418, 1407419, 1408069, 1408070, 1408739, 1408740, 1408741, 1408742, 1410178, 1410179, 1410478, 1410480, 1410990, 1411518, 1423937, 1423938
Manufactured April – June 2014
Reason of Field Safety Corrective Action:US Endoscopy received a report of a grasping wire detachment during use
Remedy Action:1) Quarantine the affected Talon grasping devices in your stock.
2) Contact your customers to arrange for return of the affected devices to you.
Athorized Representative/Importer/Distributor:Gulf Medical Co., Jeddah, (012) 6512828
Report Source:NCMDR
Source Ref. Number:736ED07C8C2B9
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: US Endoscopy.pdf