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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 014 11 14 000
Date submitted: 11/4/2014
Manufacturer:Alshifa Medical Syringes Manufacturing Company
Device Type:RAMY 0.5ml, 1ml, 5ml and 10ml insulin syringes
Description:Medical syringes, insulin syringes
Medical Device Identifier:RAMY 0.5ml, 1ml, 5ml and 10ml insulin syringes
Reason of Field Safety Corrective Action:Incorrect labeling on the package of RAMY insulin syringes
Remedy Action: For all affected products a new printing for labeling purposes has been issued.
Athorized Representative/Importer/Distributor:Alshifa Medical Syringes Manufacturing Company
Report Source:NCMDR
Source Ref. Number:4EB3263F1917F, 4F3D04286A122, 0F5D57A70F179, 202EB975581D4
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: alshifa medical syringe.pdf