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 013 07 16 000
Date submitted:	7/2/2016

Manufacturer:	Saudi Mais for Medical Products
Device Type:	Urine drainage bag with sampling port
Description:	Single use device
Medical Device Identifier:	Device Reference no : 051-2001 Device Lot No. 0527E & 1222
Reason of Field Safety Corrective Action:	Saudi mais co has recently become aware of a potential safety issue, with the urine drainage Bag with sampling port product, please ensure that all stock in your facility are made aware Of this safety issue notification and the recommended actions.
Remedy Action:	1- Determine of any stock of urine drainage bag with sampling port with the reference lot number in your stock discontinued immediately. 2- Both effected lot numbers currently available in your premises will be collected by our sales representative.
Athorized Representative/Importer/Distributor:	Saudi Mais Co. For Medical Products
Report Source:	NCMDR
Source Ref. Number:	A51AC3D0A82FA
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Saudi Mais for Medical Products.pdf

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