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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
BfArM Recall
Reference Number: mdprc 146 07 18 000
Date submitted: 7/29/2018
Manufacturer:Demophorius Ltd
Device Type:Demotek Solution Administration IV Set
Description:Injections / Infusions / Transfusions / Dialysis - transfusion kits
Medical Device Identifier:REF: IS08

LOT: 20170215
Reason of Field Safety Corrective Action:The product has shown leakage on the interconnection between titration needle and lower cover of hard chamber.
Remedy Action:-Check the product prior to attach a solution

-Do not use if any parts are not connected

-If defected product found identifying and quarantining the device
Athorized Representative/Importer/Distributor:Samir Trading and Marketing CJSC.
Report Source:BfArM
Source Ref. Number:07846/18
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Demophorius Ltd.pdf