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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 025 05 15 000
SHANGAHI CHANNELMED IMPORT & EXPORT CO LTD.
Hot Water Bottle
Hot Water Bottle 2000ml With Cover // Without Cover
Medical Device Identifier:
Batch Number: ScmhwbOO1
Lot No.: Cj14146
Barcode Number: 6955887301105
Reason of Field Safety Corrective Action:
A Client reported a case to SFDA, that he bought a Hot Water Bag from one of Al Nahdi Pharmacies without IFU. The client then filled the bag with boiling water and lay on it, which caused the bag to explode.
Instructions for Use in both Arabic and English will be added in each water bag (Attached).
Nahdi Medical Company
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.