Medical device specifications
Recall Date : 7/25/2018
Recall Class : 1
Common Device  Name: Blood Line Set (Arterial - Venous)
Brand Device Name :
Producer company : ساخت وسایل پزشکی ایران "سوپا"
Manufacturing Country : IRAN, ISLAMIC REPUBLIC OF
Model :
Serial No. : 63532C/A800/U975, 63831C/A213/U2 , 63231B/A691/U238
Importer / manufacturer company : SUPA MEDICAL DEVICES
Recall Reason :
Describe the quality problem
Date of reporting : 3/4/2018
History of the accident : -
Report type: Product Problem
Reporter Group : National Medical Device Directorate
Survey Results
Corrective action taken : Recall/Replace
Recall Status : Open
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.

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