Medical device specifications
Recall Date : 6/18/2019
Recall Class : 1
Common Device  Name: Disposable Plate
Brand Device Name :
Producer company : فارمد پليمر رايان
Manufacturing Country : IRAN, ISLAMIC REPUBLIC OF
Model : تک لبه و دولبه
Serial No. : F970217(دو لبه)- F960928-F970414 -F960821 (تک لبه)
Importer / manufacturer company : Pharmed Polymer Ryan
Recall Reason : عدم انطباق کالا با مشخصات فوق الذکر با الزامات استاندارد مربوطه
Describe the quality problem
Date of reporting : 11/26/2018
History of the accident : -
Report type: Product Problem
Reporter Group : Health Centers
Survey Results
Corrective action taken : Recall/Replace
Recall Status : Open
Description : جمع آوری کالا با مشخصات فوق الذکر و جایگزینی آن 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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