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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 030 12 15 000
Date submitted: 12/9/2015
Manufacturer:Covidien
Device Type:Endo GIA™ Ultra Universal Stapler Handles
Description:Stapler Handles
Medical Device Identifier:Item Codes : EGIAUSHORT, EGIAUSTND, EGIAUXL LOT : Please refer to attachment
Reason of Field Safety Corrective Action:This Field Safety Corrective Action (FSCA) is being conducted following customer reports of instruments failing to fire or partially firing and reports of the instrument articulating lever disengaging during use.
Remedy Action:1. Please quarantine and discontinue use of the affected item codes listed above.

2. Please return affected product.
Athorized Representative/Importer/Distributor:Covidien AG
Report Source:NCMDR
Source Ref. Number:CCBACD5D54304
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Covidien.pdf