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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 095 03 17 000
Date submitted: 3/27/2017
Manufacturer:Abbott
Device Type:NC Trek RX Coronary Dilatation Catheter , NC Traveler RX Coronary Dilatation Catheter and NC Tenku RX PTCA Balloon Catheter
Description:Catheters
Medical Device Identifier:Multiple part numbers of the affected products are provided in the attached FSN.
Reason of Field Safety Corrective Action:Product from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
Remedy Action:Return all unused identified products to Abbott Vascular
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv
Report Source:NCMDR
Source Ref. Number:5C5A0F07EF1BB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott.pdf