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 032 10 16 000
Date submitted:	10/4/2016

Manufacturer:	Smith & Nephew
Device Type:	SUCTION PUNCH
Description:	SUCTION PUNCH
Medical Device Identifier:	Product No. 2685 Description: 5.2mm Suction Punch Batch No. 50568539, 50560357, 50559396, 50555648 & 50549486
Reason of Field Safety Corrective Action:	The weld penetration was found to be under specification potentially causing the distal tip to bend or break.
Remedy Action:	1. Locate and quarantine affected unused devices immediately. 2. Return quarantined product to your national Smith & Nephew agency/distributor. 3. Complete the return slip and fax it to your national Smith & Nephew agency/distributor. 4. Please make sure this safety information is passed on to all those who need to be aware of it within your organization. 5. Please maintain awareness on this notice and resulting action until the Field Safety Corrective Action is terminated to ensure effectiveness of the action.
Athorized Representative/Importer/Distributor:	Alhaya medical co.
Report Source:	NCMDR
Source Ref. Number:	80810CE73F233
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	SMITH & NEPHEW.pdf

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