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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 011 09 21 000
Date submitted: 9/8/2021
Manufacturer:Smiths Medical International Limited
Device Type:Level 1 Fast Flow Fluid Warming Systems and Level 1 NORMOFLO Irrigation Systems
Description:Warming Units, Blood/Intravenous Solution
Medical Device Identifier:Level 1 Fluid Warmer: H-1000, H-500
Level 1 Fluid Warming System: H-1025, H-1028, H-1200
Level 1 Normothermic I.V. Fluid Administration Set: D-100, D-300, D-50, D-60HL, DI-100, DI-300, DI-50, DI-60HL, D-70, DI-70
NORMOFLO Fluid Warmer: H-1100, H-1129
NORMOFLO Irrigation Warming Set: IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Reason of Field Safety Corrective Action:Aluminum ion may leach into warmed fluids with the above systems.
Remedy Action:No product return is necessary. To mitigate the risk of exposure to aluminum, refer to -instructions for all customers and users- in the attached FSN.
Athorized Representative/Importer/Distributor:almadar medical Est.
Report Source:NCMDR
Source Ref. Number:CCE5CACF26370
SFDA Comments:SFDA urges all hospitals that have devices subjected to this FSCA to contact the company.
Attachments: Smiths Medical International Limited.pdf