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 100 06 15 000
Date submitted:	6/18/2015

Manufacturer:	Medtronic Inc
Device Type:	DLP Femoral Arterial Cannula, DLP Femoral Cannula and Insertion Kit
Description:	CardioVascular Cannula
Medical Device Identifier:	Product : DLP Femoral Arterial Cannula Model Number : 57414, 57417, 57421 Affected Lot Numbers : Please see attachment Product : DLP Femoral Cannula and Insertion Kit Model Number : 96017, 96021
Reason of Field Safety Corrective Action:	Medtronic is initiating a voluntary Recall due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion circuit tubing.
Remedy Action:	1. Immediately identify and quarantine all unused listed product in your inventory. 2. Return all listed product in your inventory to Medtronic. Your Medtronic sales representative will assist you with the return of the product and will help you with ordering replacement product as necessary.
Athorized Representative/Importer/Distributor:	Gulf Medical Co.
Report Source:	NCMDR
Source Ref. Number:	EF4D2E56161D6
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic Inc.pdf

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