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 001 04 13 000
Date submitted: 4/1/2013
Manufacturer:Perouse Medical
Device Type:Flamingo Inflation devices
Description:Inflation devices
Medical Device Identifier:See attached
Reason of Field Safety Corrective Action:The primary packaging, constituted of blister has in some cases a crack leading to a risk of loss of sterility of the device
Remedy Action:Stop immediately distributing the device and quarantine the products.
Athorized Representative/Importer/Distributor:Life Pulse Medical Company , Riyadh, (01) 4805624
Report Source:NCMDR
Source Ref. Number:DD8BCD6D492EB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Perouse Medical.pdf