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
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.



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