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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 160 08 15 000
Date submitted: 8/24/2015
Manufacturer:Medtronic Inc
Device Type:TRITON™ Pneumatic High Torque Hand Piece Hose
Description:High Torque Hand Piece Hose
Medical Device Identifier:Model Number: 720101 Serial Numbers: 152369, 152377, 152379, 152380
Reason of Field Safety Corrective Action:The reason for the removal is that MicroAire Surgical Instruments has detected potential workmanship issues that may result in a decreased flow of nitrogen through the hose.
Remedy Action:Return all potentially affected product in your inventory to Medtronic. Your Medtronic Representative will assist you with this process.
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:A18AE5B2202E2
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic Inc.pdf