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 072 03 17 000
Date submitted:	3/19/2017

Manufacturer:	Medtronic
Device Type:	Curity™ Eye Pad Oval and Curity™ Sodium Chloride Dressing
Description:	Dressing/wound
Medical Device Identifier:	Item Code : Item Description ( Lot Number beginning with; Expiration Date) - 2841: Covidien Curity™ Eye Pad Oval ( 12, 13, 14, 15, 16; From 2017-02 through 2021-11) - 3339 : Covidien Curity™ Sodium Chloride Dressing : ( 14, 15, 16; From 2017-02 through 2019-11 )
Reason of Field Safety Corrective Action:	This Field Safety Corrective Action (FSCA) is being conducted due to the potential for the sterile packaging to be compromised.
Remedy Action:	Medtronic requests that you quarantine and return any unused affected products
Athorized Representative/Importer/Distributor:	Medtronic Saudi Arabia
Report Source:	NCMDR
Source Ref. Number:	0B5C2A9FD2202
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic.pdf

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