Medical device specifications
Recall Date : 11/24/2018
Recall Class : 2
Common Device  Name: hemodialysis unit
Brand Device Name : Baxter AG
Producer company : BAXTER AG
Manufacturing Country : SWITZERLAND
Model : AK98
Serial No. : تمامی شماره سریال ها
Importer / manufacturer company : Kar-O-Andisheh
Recall Reason : در صورت استفاده از فیلترهای الترافیلتراسیون U9000 بیش از مدت زمان تعیین شده جهت استفاده (60 روزه یا 100 بار درمان) و نشت در کلاهک این فیلترها، امکان اعمال فیلتراسیون بیش از اندازه در بیماران با وزن پایین و حساس (به ویژه کودکان) و نوسانات فشار خون وجود دارد.
Describe the quality problem
Date of reporting : 9/29/2018
History of the accident : -
Report type: Product Problem
Reporter Group :
Survey Results
Corrective action taken : Notification/Patient Monitoring
Recall Status : Open
Description :

The recall of medical Device is classified into three classes according to the severity of the risks of their safety and performance problems:
Class 1: The most serious type of call. In this class there is a possibility of serious injury and death.
Class 2: Potential damage is temporary and reversible, or the probability of serious injury and death is negligible.
Class 3: The possibility of damage is negligible, while the labeling rules or documents accompanying the General Office or the manufacturer have been violated.

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