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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 164 07 13 000
Date submitted: 7/23/2013
Manufacturer:B Braun Medical Inc
Device Type:Needles , needles for access port , WINGED SURECAN needles
Description:WINGED SURECAN needles
WINGED SURECAN needles Y site
Medical Device Identifier:Articles No : 4448332 , 4448340 , more lots in attached file
Reason of Field Safety Corrective Action:Potential defect in the packaging of the batches , This packaging defect could compromise the sealing integrity of the single unit packaging and therefore the product sterility. The patient might be then exposed to a potential risk of infection.
Remedy Action:Please remove them from your inventory and return it to the manufacture
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv , Riyadh , (011) 4780555
Report Source:NCAR
Source Ref. Number:FR-2013-07-18-042
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: FR-2013-07-18-042 FSN.pdf