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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NCAR Recall

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Reference Number:	mdprc 038 01 11 000
Date submitted:	1/18/2011

Manufacturer:	France Chirurgie Instrumentation SAS (FCI)
Device Type:	Silicone oil injection cannula.
Description:	injection cannula.
Medical Device Identifier:	Lot/batch no.: 0106446 and 0106448 commercial codes S5.7604 and S5.7606.
Reason of Field Safety Corrective Action:	May be responsible to stop the normal fluid flow and then makes the product non useable.
Remedy Action:	Return without any delay any product which has not been used and which is in your stock. If applicable, we also ask you to contact yours customers asking them to return the products not used in their sites.
Athorized Representative/Importer/Distributor:	N/A
Report Source:	http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
Source Ref. Number:	FR-2011-01-17-003
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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