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 150 06 15 000
Date submitted:	6/28/2015

Manufacturer:	BIOTRONIK UK Ltd
Device Type:	Orsiro ,Sirolimus Eluting Coronary Stent System
Description:	Stent System
Medical Device Identifier:	Device Name : Orsiro Size : 2.75/40 REF number : 391240 LOT : 02152670, 02152671 Device Name : Orsiro Size : 3.0/40 REF number : 391241 LOT : 02152672, 02152673
Reason of Field Safety Corrective Action:	It was determined that 4 lots of the Orsiro stent system were wrongly labeled
Remedy Action:	-Discontinue any further use of the affected Orsiro lots. -Identify and remove all the affected Orsiro units from your inventory
Athorized Representative/Importer/Distributor:	Al-Faisaliah Medical System
Report Source:	NCMDR
Source Ref. Number:	3E5F4F37861A9
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	BIOTRONIK.pdf

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