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 074 03 17 000
Date submitted:	3/19/2017

Manufacturer:	Smith & Nephew
Device Type:	Disposable Kits for Patient Positioning
Description:	Kits, disposable
Medical Device Identifier:	Product No. : Description - 72202931 : SPIDER ANKLE STABILIZATON KITS - 72203833 : SPIDER2 SHOULDER STABLIZATION KITS - 7210559 : DISPOSABLE FACE MASK - 7210573 : KIT STABILIZATION SHOULDER - 7210574 : KIT STABILIZATION ELBOW - 72201550 : SMALL WRIST STABILIZATION KITS - 72203238 : LEG STABILIZATON KITS - 72203300 : SWITCH DRAPE Date: February 2016 through September 2016 Lots: See Attached
Reason of Field Safety Corrective Action:	Smith & Nephew, Inc. has initiated a Field Correction for several lots of Disposable Kits for Patient Positioning due to a labeling error.
Remedy Action:	1. Please inspect your inventory and complete the attached Inventory Correction Certification Form. 2. If you have the affected products, please maintain awareness of this notice.
Athorized Representative/Importer/Distributor:	Alhaya medical co.
Report Source:	NCMDR
Source Ref. Number:	18D2F5E4DA39D
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Smith & Nephew.pdf

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