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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 070 01 18 000
Date submitted: 1/21/2018
Manufacturer:Medtronic
Device Type:AFFINITY® NT Cardiotomy/Venous Reservoir (CVR) Stand-Alone
Description:Reservoir, blood, cardiopulmonary bypass
Medical Device Identifier:All non-expired Lot Numbers of Product Code: 540 and 540T
Reason of Field Safety Corrective Action:During internal testing, Medtronic identified the potential for a breach of the sterile barrier in all lot numbers of the above listed products.
Remedy Action:Immediately identify and quarantine all unused affected product in your inventory. Return all affected product in your inventory to Medtronic. Your Medtronic Representative can assist you in the return and replacement of this product as necessary.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:1A9A076AE0205
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf