SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 175 12 13 000
Date submitted:	12/26/2013

Manufacturer:	Edwards Lifesciences
Device Type:	Femoral Arterial and Venous Cannulae.
Description:	Cannulae, Venous
Medical Device Identifier:	Femoral Arterial and Venous Cannulae Product Numbers.: ( Please see attached )
Reason of Field Safety Corrective Action:	Edwards Lifesciences has identified an increase in the use of Femoral Arterial and Venous Cannula in adult and pediatric populations in a manner that is not intended resulting in leaks.
Remedy Action:	Please review this field action notice to understand the changes that Edwards has made to device use. Additional Contraindications for Use Femoral Access cannulae are contraindicated for long-term use (>6 hrs), including Extra Corporeal Membrane Oxygenation (ECMO) procedures. Devices are contraindicated for placement in vasculature outside of the femoral artery or vein.
Athorized Representative/Importer/Distributor:	Arabian Health Care Supply Co. (AHCSC), (011) 4747444
Report Source:	NCMDR
Source Ref. Number:	D45A741BD4291
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Edwards Lifesciences.pdf

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