Medical device specifications
Recall Date : 7/21/2019
Recall Class : 1
Common Device  Name: Oxygen Mask
Brand Device Name :
Producer company : تجهیزات پزشکی بهار طب امین
Manufacturing Country : IRAN, ISLAMIC REPUBLIC OF
Model : -
Serial No. : تمامی سری ساخت ها
Importer / manufacturer company : Medical Devices Manufacturing Company of Bahar Teb Amin
Recall Reason : بسته بودن راه خروجی هوا در ماسک اکسیژن با مشخصات فوق الذکر
Describe the quality problem
Date of reporting : 6/18/2019
History of the accident : 6/11/2019
Report type: Product Problem
Reporter Group : Health Centers
Survey Results
Corrective action taken : Recall/Replace
Recall Status : Terminate
Description : جمع آوری کالا با مشخصات فوق الذکر و جایگزینی آن توسط سازنده
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