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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 078 05 17 000
Date submitted: 5/16/2017
Manufacturer:Medtronic
Device Type:Covidien 5 mm Endo Peanut Devices
Description:Carriers, Surgical, Cotton/Sponge/Swab, Endoscopic
Medical Device Identifier:Item No. 173019; Lot Nos. M5K04X through M7A01X; EXP OCT 2020 through JAN 2022
Reason of Field Safety Corrective Action:Cotton Tip May Disengage
Remedy Action:Return the affected device to the manufacturer.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:CCF2F799BA408
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf