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 036 05 17 000
Date submitted:	5/9/2017

Manufacturer:	C R Bard Inc.
Device Type:	Caliber Inflation Device
Description:	Inflation Device
Medical Device Identifier:	Product Catalog Code: CL3030 Description: Caliber Inflation Device Lot number: Batch code starting from: 1504XXXX to 1512XXXX 1601XXXX to 1612XXXX
Reason of Field Safety Corrective Action:	Perouse Medical has been informed, by a few customers, of a potential defect of the Caliber inflation device primary packaging (blister), which may compromise the device sterility.
Remedy Action:	Return the affected device to the manufacturer.
Athorized Representative/Importer/Distributor:	C.R. BARD Saudi Arabia
Report Source:	NCMDR
Source Ref. Number:	E45FE3D5F53F0
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	C.R. BARD GmbH.pdf

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