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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 139 09 12 000
Date submitted: 9/17/2012
Manufacturer:3M Sanayi ve Ticaret A.Ş.
Device Type:Surgical Drapes, 3M Steri-Drape™ Surgical Drapes, 3M Steri-Drape™ Surgical Drape Packs and 3M Gown
Description:Surgical Drapes
Medical Device Identifier:3M Steri-Drape™ Surgical Drape Packs and 3M Gown
Reason of Field Safety Corrective Action: Upon a voluntary inspection of the manufacturing process, a potential impairment of the sterility of the above mentioned products were detected.
Remedy Action: Stop using products immediately Screen your warehouse to check whether you keep products and if so please make sure that they will not be used any more 3M representative will organize procedure on returning the goods to 3M.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:TR-2012-07-13 -001
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments