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 143 03 16 000
Date submitted:	3/17/2016

Manufacturer:	Covidien LLC
Device Type:	Curity™ All Purpose Gauze Sponges, Curity™ X-Ray Detectable Laparotomy Sponges, Kerlix™ X-Ray Detectable Laparotomy Sponges, Vistec™ X-Ray Detectable Sponges
Description:	Sponges for x-ray systems
Medical Device Identifier:	Model : 397310, 4034, 8047, 4031, 4037, 6022, 6056, 6522, 6534, 6545, 6556, 7319, 7321
Reason of Field Safety Corrective Action:	This Field Safety Corrective Action (FSCA) is being conducted due to the potential for the sterile barrier to be compromised at the package seal.
Remedy Action:	Medtronic requests that you quarantine and return any unused products of the items/lots detailed on Attachment A. Unused products from the affected item codes and lots should be returned as described in the Required Actions section in attachment.
Athorized Representative/Importer/Distributor:	Covidien AG
Report Source:	NCMDR
Source Ref. Number:	E7797F679F2E5
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Covidien LLC.pdf

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