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 029 10 18 000
Date submitted: 10/8/2018
Manufacturer:Clearstream Technologies Ltd
Device Type:LifeStream Balloon Expandable Vascular Covered Stent
Description:Balloon vascular stent
Medical Device Identifier:Part Numbers: LSM0800526, LSM0800537, LSM0800626, LSM0800637, LSM0800616, LSM0800658., LSM0801058, LSM0801238, ...(For the full list of affected devices, please check attachment)
Reason of Field Safety Corrective Action:ClearStream Technologies is issuing a Field Safety Notice to advise users of an update to the Instructions For Use (IFU) for the LifeStream Balloon Expandable Vascular Covered Stent, per the enclosed labelling attachment (Attachment 1). This information will be included in the labelling of all future units distributed by ClearStream (BD).
Remedy Action:1. Pass this Field Safety Notice to all personnel involved with the use of the LifeStream Balloon Expandable Vascular Covered Stent System.

2. Ensure that the contents of this Field Safety Notice is understood by the associated personnel.

3. The enclosed labelling update (Attachment 1) is to be used in conjunction with the LifeStream Balloon Expandable Vascular Covered Stent Instructions for Use (IFU) for all LifeStream devices currently distributed.

4. If you have further distributed this product then please identify the organisation and notify them at once of this notification. You may include a copy of this letter in your notification.

5. Please complete the attached Reply Effectiveness Check Form and return to Saudi Arabia either by fax to: +966 11 4555072. Alternatively this can be emailed to: Ahmed.Shebah@crbard.com
Athorized Representative/Importer/Distributor:Arabian Trade House Est.
Report Source:NCMDR
Source Ref. Number:AD14DB2A51217
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Clearstream Technologies.pdf