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 125 12 14 000
Date submitted:	12/23/2014

Manufacturer:	ASPIDE MEDICAL
Device Type:	Endorec, Endo-rectal trocar
Description:	Single-use , MTERPACK ENDOREC
Medical Device Identifier:	Reference MTERPACK All Lots
Reason of Field Safety Corrective Action:	MEDICAL noted that the sealing of the outer blister can be weakened.
Remedy Action:	Identify and quarantine affected devices. A credit note will be issued for distributors holding one or more device(s) concerned by this recall. Any product returned after 15th February 2015 will not receive credit note.
Athorized Representative/Importer/Distributor:	N/A
Report Source:	NCAR
Source Ref. Number:	INC-FR-14-12-000078
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	FR-2014-12-15-075_FSN_151214.pdf

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