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 :
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.



All Rights Reserved Medical Device Directorate of Islamic Republic of Iran.

Powered By NOICT