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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 066 12 16 000
Date submitted: 12/14/2016
Manufacturer:Baxter Corp
Device Type:Central Water Plant (CWP) Reverse Osmosis Units
Description:Water Purification Systems, Reverse Osmosis
Medical Device Identifier:Product Codes: 106278, 102695, 100340, 100976, 100975, 103310, 100474 and 102036.
Multiple serial numbers
Reason of Field Safety Corrective Action:Baxter AG is issuing a device correction for specific models of the Central Water Plant (CWP) Reverse Osmosis Units in order to correct the insufficient crimping of the cables within the main pump.
Remedy Action:Baxter is organizing the replacement of the Central Water Plant pump components that are impacted by the issue.
Athorized Representative/Importer/Distributor:Baxter AG
Report Source:NCMDR
Source Ref. Number:3DB4DD93FE35F
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Baxter.pdf