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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 160 08 15 000
TRITON™ Pneumatic High Torque Hand Piece Hose
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.
Return all potentially affected product in your inventory to Medtronic. Your Medtronic Representative will assist you with this process.
Gulf Medical Co.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.