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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 137 04 15 000
Date submitted: 4/29/2015
Manufacturer:PRINCE MEDICAL
Device Type:Nasobiliary drainage catheters 1-DRAIN
Description:Drainage biliary catheter
Medical Device Identifier:Multiple references are provided in the attached FSN.
Reason of Field Safety Corrective Action:Prince Medical has recently conducted new biocompatibility tests on the nasobiliary drainage catheters. The results of the tests showed a cytotoxic potentiel of these products.
Remedy Action:Prince Medical decided to stop the production and the delivery of nasobiliary drainage catheters. The manufacturer asks the destruction of all the products in stock
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:FR-2015-04-27-024
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: PRINCE MEDICAL.pdf