Medical device specifications
Recall Date : 4/28/2019
Recall Class : 2
Common Device  Name: Infusion Buret Set
Brand Device Name :
Producer company : تولیدی تجهیزات پزشکی هلال ایران
Manufacturing Country : IRAN, ISLAMIC REPUBLIC OF
Model : -
Serial No. : P60530A
Importer / manufacturer company : Helal Iran Medical Device Co
Recall Reason : - وجود نشتی از محل اتصال به سه راهی آنژیوکت - اشکال در پیچ تنظیم قطرات به طوری که هیچ کاربردی در کنترل جریان قطرات ندارد.
Describe the quality problem
Date of reporting : 12/11/2018
History of the accident : -
Report type: Product Problem
Reporter Group : Health Centers
Survey Results
Corrective action taken : Recall
Recall Status : Open
Description : جمع آوری میکروست با مشخصات فوق الذکر توسط سازنده

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.

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