SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCAR Recall

Back

Reference Number:	mdprc 111 03 12 000
Date submitted:	3/31/2012

Manufacturer:	Bristol-Myers Squibb Pharmaceuticals Ltd.
Device Type:	ViaSpan
Description:	ViaSpan is a solution for the preservation of kidney, liver and pancreas.
Medical Device Identifier:	Serial no.: na, Lot/batch no.: All lots manufactured in July 2011 and to date
Reason of Field Safety Corrective Action:	There is a potential for product contamination. Bacterium Bacillus cereus has been cultured from the Fresenius production line (media fill process), not from the product itself but such testing is ongoing.
Remedy Action:	Please be aware of the problem and the cessation of distribution of ViaSpan whilst the investigation is ongoing.
Athorized Representative/Importer/Distributor:	N/A
Report Source:	NCAR
Source Ref. Number:	UK-2012-03-28-059
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

View History