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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 113 05 11 000
Date submitted: 5/31/2011
Manufacturer:Smith & Nephew inc
Device Type:REMOVE Universal Adhesive Remover Wipes
Description:Adhesive Removers
Medical Device Identifier:Remove Universal Adhesive Remover Wipes. Catalog nb: 403100. Skin PREP Protactive Wipes. Catalog nb: 420400. Please check the attached document for affected lot numbers.
Reason of Field Safety Corrective Action:The recalled / affected lots were made in the same facility as other wipe products, including wipes, swabs and swab sticks, that are subject of other voluntary recalls due to a potential bacterial contamination isuue of these products
Remedy Action:Please discard and return the packets of REMOVE and Skin PREP with Smith & Nephew lot numbers listed above
Athorized Representative/Importer/Distributor:Medical Oasis, Riyadh (01) 4037000
Report Source:NCMDR
Source Ref. Number:459643DE5324F
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: InHealth_Recall[1].pdf