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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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NCAR Recall

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Reference Number:	mdprc 023 09 12 000
Date submitted:	9/3/2012

Manufacturer:	Shanghai Shenfeng Medical & Health Articles Co Ltd
Device Type:	Gel, ultrasonic coupling, L- Gel Ultrasound Transmission Gel – 5 ltr & 250 mls
Description:	Gel, ultrasonic coupling
Medical Device Identifier:	Catalogue number: LG5000 & LG250; Lot/batch no.: All Batch numbers
Reason of Field Safety Corrective Action:	5 liter plastic containers of gel appeared to be contaminated. The gel contained a diffusely discoloured gel with large irregular focal pink and grey matter that has a shape not unlike coral.
Remedy Action:	All suppliers of L-Gel ultrasound gel have been requested to quarantine any stock in their warehouse and recall any stock that has been supplied.
Athorized Representative/Importer/Distributor:	N/A
Report Source:	NCAR
Source Ref. Number:	AU-2012-08-21-004
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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