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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 059 06 15 000
Date submitted: 6/10/2015
Manufacturer:Alcon Laboratories Inc.
Device Type:Accurus Standalone Probe
Description:Probes
Medical Device Identifier:Models are tabulated in the attachment
Reason of Field Safety Corrective Action:Alcon is conducting a voluntary recall for specific lots and catalog numbers of its Accurus Vitrectomy Probes after quality review processes discovered an insufficient seal on the outside packaging, potentially affecting the sterility of the product.
Remedy Action:Alcon has initiated a product removal / recall of all lots affected in Saudi Market. For any questions, contact Alcon Laboratories using the details in the attached letter.
Athorized Representative/Importer/Distributor:Al Amin Medical Instruments Co. Ltd.
Report Source:NCMDR
Source Ref. Number:BB131728FE20B
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Alcon Laboratories Inc..pdf