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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 032 10 16 000
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.
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.
Alhaya medical co.
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
SMITH & NEPHEW.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.