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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 023 12 16 000
Yafho Bio - Technology CO. Ltd
ULTRASOUND PROBE COVER KIT WITH GEL
single use device
Medical Device Identifier:
ITEM NUMBER: 654005
ITEM NAME: ULTRASOUND PROBE COVER KIT WITH GEL
BATCH NUMBER: 20150701 / 20160201
Reason of Field Safety Corrective Action:
In the course of our post market surveillance activities we observed that the ultrasound probe cover kit with gel was found the Burkholderia multivorans, Bukholderia cenocepacia, Bacillus beringensis, Bacillus circulans inside, which pointed that the gel was the source of pollution.
We kindly ask you to initiate the following activities immediately and with priority:
A. Please identify, quarantine and return affected devices.
B. Please do not use affected devices anymore.
C. Please destroy the affected devices.
D. Please confirm the receipt of this information.
electronic technicains est
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Yafho Bio - Technology.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.