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 099 12 18 000
Date submitted:	12/24/2018

Manufacturer:	Medtronic SA
Device Type:	Covidien Parietex Composite Parastomal Mesh
Description:	Mesh Products for Hernia Repair
Medical Device Identifier:	Item codes: PCOPM15, PCOPM20
Reason of Field Safety Corrective Action:	Medtronic records indicate that your facility purchased this product more than five years ago and it is beyond its labeled expiration date.
Remedy Action:	Medtronic’s initial communication requested that customers with inventory quarantine and return any unused products of the item codes detailed above. Customers who have distributed Covidien Parietex™ composite parastomal mesh listed above, should promptly forward the information from this letter and the initial letter to those recipients. All unused products from the affected item codes must be returned.
Athorized Representative/Importer/Distributor:	Medtronic Saudi Arabia
Report Source:	NCMDR
Source Ref. Number:	B61C067B6A1BD
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic SA.pdf

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