SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 023 12 16 000
Date submitted:	12/6/2016

Manufacturer:	Yafho Bio - Technology CO. Ltd
Device Type:	ULTRASOUND PROBE COVER KIT WITH GEL
Description:	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.
Remedy Action:	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.
Athorized Representative/Importer/Distributor:	electronic technicains est
Report Source:	NCMDR
Source Ref. Number:	C1F50DF9BA376
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Yafho Bio - Technology.pdf

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