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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 031 05 11 000
Date submitted: 5/8/2011
Manufacturer:Becton Dickinson & Co. (BD)
Device Type:BD Venflon, Peripheral IV Catheter
Description:Catheter, intravascular, peripheral
Medical Device Identifier:BD Venflon 22GA, 0.8 x 25mm, Peripheral IV Catheter, Ref#: 391451, Lot#: 10F2941E
Reason of Field Safety Corrective Action:Incorrectly labelled shelf boxes.
Remedy Action:To assist Becton Dickinson with this action, please be aware of the analysis attached and communicate the information within your organization. Based on a health risk assessment, BD is not requesting that your organization ceases to use the affected product. However if your organization requires the withdrawal of any affected products please contact the BD office identified below. Please complete and return the attached Response Card to the local BD office identified in order to confirm receipt of this advisory notice.
Athorized Representative/Importer/Distributor:Alhaya medical co., Riyadh, (01) 465 5075
Report Source:H:\NCMDR\Recalls\Recalls from NCAR\Orginal Reports\Not Confidential\2011\May\8
Source Ref. Number:SE-2011-05-04-016
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: FSN_Customer_Final.pdf