X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 002 01 19 000
Date submitted: 1/3/2019
Manufacturer:Boston Scientific
Device Type:Flexima Duodenal Bend Biliary Stent with Delivery System
Description:Stent with Delivery System
Medical Device Identifier:Material Number (UPN): M00539220, M00539210

Lot/Batch Number: 22960202, 22960201

GTIN: 08714729162537, 08714729162520

Expiry date: 18 November 2021
Reason of Field Safety Corrective Action:Boston Scientific has determined through internal inspection, for affected products, the sterile barrier may contain seal defects.
Remedy Action:1- Please immediately discontinue use of the Boston Scientific product reported in the list and remove all of the affected units from your inventory, regardless of where these units are stored in your facility. Segregate the units in a secure place, pending return to Boston Scientific.

2- Please complete the attached Verification Form even if you do not have any product to return.

3- When completed, please return the Verification Form to your local Boston Scientific office for the attention of «Customer_Service_Fax_Number» on or before 18 January 2019.

4- If you have products to return, please package them in an appropriate shipping box and contact «Customer_Service_Tel» of your local Boston Scientific office, to arrange return.

5- Please pass this notice to any healthcare professional from your organization that needs to be aware and to any organization where the potentially affected devices have been transferred (If appropriate). Please provide Boston Scientific with details of any affected devices that have been transferred to other organizations (if appropriate).
Athorized Representative/Importer/Distributor:Gulf Medical Co.
Report Source:NCMDR
Source Ref. Number:AA4D9C1192236
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Boston Scientific.pdf