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 034 08 12 000
Date submitted:	8/14/2012

Manufacturer:	3M Health Care Ltd
Device Type:	Drape™ Surgical Drape Packs, Pediatric cvc Drape
Description:	Surgical Drapes
Medical Device Identifier:	Lot Number:03122011-A Expiry Date:3-12-2013
Reason of Field Safety Corrective Action:	Upon a voluntary inspection of the manufacturing process, a potential impairment of the sterility of the above mentioned products were detected.
Remedy Action:	Stop using products Immediately If you have the products a 3M representative will organize procedure on returning the goods to 3M Saudi Office. Therefore please do not dispose any product.
Athorized Representative/Importer/Distributor:	3M company, Riyadh, (01) 4650052
Report Source:	NCMDR
Source Ref. Number:	B3842937F0287
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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