Medical device specifications
Recall Date : 7/21/2019
Recall Class : 2
Common Device  Name: 3Way Stop Locked
Brand Device Name :
Producer company : پيشگام ايده آل خاورميانه
Manufacturing Country : IRAN, ISLAMIC REPUBLIC OF
Model : -
Serial No. : تمامی سری ساخت ها
Importer / manufacturer company : Pishgam idehal khavarmianeh
Recall Reason : فیکس نشدن ست تزریق داخل سه راهی با مشخصات فوق الذکر
Describe the quality problem
Date of reporting : 3/7/2019
History of the accident : -
Report type: Product Problem
Reporter Group : Health Centers
Survey Results
Corrective action taken : Recall/Replace/Modification / Adjustment
Recall Status : Open
Description : شرکت سازنده قبل از دریافت گزارش در سامانه MDR ، اقدام به اصلاح و رفع عیوب کالا با مشخصات فوق الذکر نموده است.

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