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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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U.S FDA Recall

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Reference Number:	mdprc 053 09 14 000
Date submitted:	9/17/2014

Manufacturer:	BD Biosciences
Device Type:	BD BBLTM Vancomycin Screen Agar
Description:	It is used to test enterococci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
Medical Device Identifier:	Product Number: 4080291 4042217 4048040 4052349 4058242 4073274 4127728
Reason of Field Safety Corrective Action:	BD has confirmed reports that the referenced lots of Vancomycin Screen Agar may have exhibited breakthrough growth of vancomycin susceptible Enterococcus species control organisms.
Remedy Action:	Please discontinue use of these lot numbers and discard any remaining packages.
Athorized Representative/Importer/Distributor:	Becton Dickinson B.V., Riyadh, (011) 4727933
Report Source:	http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=129481
Source Ref. Number:	Z-2628-2014
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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