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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 04 18 000
Date submitted: 4/22/2018
Manufacturer:Alrazi Pharma Industries
Device Type:Liquid Acid Concentrate for Haemodialysis-HDA08
Description:Haemodialysis, Liquid Acid Concentrate
Medical Device Identifier:Acid Concentrate for Haemodialysis-HDA08
Lot# 8016040
Reason of Field Safety Corrective Action:Product from the identified lot may exhibit high conductivity with the Haemodialysis Machine and raise the alarm during the operation. This action does not affect the patients but it will stop the Dialysate flow if conductivity is out of limits. By adjusting the level of Acid concentrate and Bicarbonate solution can be eliminate this alarm.
Remedy Action:• Please immediately stop using this Liquid Acid Concentrate for Haemodialysis-HDA08 from this lot# 8016040.
• Please review your inventory, complete, and return the attached Effectiveness Check Form.
• Return all Used/Unused Identified Products to Al Razi Pharma Ind.
• Share this notification with other relevant personnel in your organization.
Athorized Representative/Importer/Distributor:Alrazi Pharma Industries
Report Source:NCMDR
Source Ref. Number:21B66A3A06181
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Alrazi Pharma Industries.pdf