OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
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