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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 032 10 16 000
Date submitted: 10/4/2016
Manufacturer:Smith & Nephew
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