SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

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

View History