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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 028 04 18 000
Date submitted: 4/4/2018
Manufacturer:Terumo Cardiovascular Systems Corporation
Device Type:Sarns TCM and TCM II Cooling and Heating Systems
Description:HX2 Temperature Management Systems
Medical Device Identifier:HX2™ Temperature Management Systems
Reference Number: AA-2018-002-C

Catalog Number: 15747, 4415, 4416, 164925,164935, 164930, 164940, 809810
Reason of Field Safety Corrective Action:As part of on-going discussions with the U.S. Food and Drug Administration (FDA) regarding cooler-heater cleaning guide adequacy, Terumo Cardiovascular Systems (Terumo CVS) has updated its cooler-heater instructions for use (cleaning guides). Despite the lack of confirmed complaints for infection associated with the use of any Terumo CVS cooler-heater device, Terumo CVS is issuing updates to its cleaning guides for specific products in order to provide customers with the most up-to-date information possible.
Remedy Action:Discard your current Sarns TCM or TCM II Cooling and Heating Systems, or HX2 Temperature Management Systems cleaning guides.
Review this notice and the attached updated cleaning guides, and ensure that all users receive notice of the updated cleaning guides.
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB
Report Source:NCMDR
Source Ref. Number:EAD2448C8B317
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Terumo Cardiovascular Systems Corporation.pdf