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 095 08 14 000
Date submitted:	8/21/2014

Manufacturer:	Maquet Cardiopulmonary AG
Device Type:	ACROBAT V and ACROBAT SUV Systems and the XPOSE 3 and XPOSE 4 Devices
Description:	Suture, heart surgery
Medical Device Identifier:	Product Name : ACROBAT V Vacuum Off-Pump System Product Code/REF Number : OM-9100S Product Name : ACROBAT SUV Vacuum Off-Pump System Product Code/REF Number : OM-9000S Product Name : AXIUS XPOSE 3 Access Device Product Code/REF Number : XP-3000 Product Name : XPOSE 4 Access Device Product Code/REF Number : XP-4000
Reason of Field Safety Corrective Action:	An internal finding identified the presence of pinholes/cuts in some of the tyvek pouches of the vacuum tubing sets included as an accessory to these products. There is a potential for the pouch’s integrity to be compromised.
Remedy Action:	Please examine your inventory immediately to determine if you have any of the products listed. If so, please remove the affected products, place in a secure location and return them to the manufacturer.
Athorized Representative/Importer/Distributor:	Al-Faisaliah Medical System
Report Source:	NCMDR
Source Ref. Number:	EFDEBF8BB03C7
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Maquet.pdf

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