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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 093 03 17 000
Date submitted: 3/26/2017
Manufacturer:Welcare Industries
Device Type:Easyderm wipes
Description:Body Cleansing system
Medical Device Identifier:Product Part No. : 95600 Lot No.: W16160NA
Reason of Field Safety Corrective Action:There is a potential contamination by Burkholderia cepacia.
Remedy Action:Return the affected device to the manufacturer
Athorized Representative/Importer/Distributor:Commercial & Maintenance Co. For Technical Equipment
Report Source:NCMDR
Source Ref. Number:B2F4D17549335
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Welcare (FSN).pdf