SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 071 01 16 000
Date submitted:	1/19/2016

Manufacturer:	Baxter Healthcare
Device Type:	HomeChoice/HomeChoice PRO Automated PD device
Description:	peritoneal dialysis system
Medical Device Identifier:	5C8310, and R5C8320 - All Lot numbers
Reason of Field Safety Corrective Action:	Baxter Healthcare Corporation is updating the HomeChoice Patient At-Home Guide Addendum to include a discussion of the expected operating sounds associated with all HomeChoice and HomeChoice PRO devices. The new labeling will address the following: The HomeChoice cycler utilizes an air (pneumatic) pump; some sounds related to the operation of this pump are expected as part of normal operation of the HomeChoice cycler.
Remedy Action:	Baxter Healthcare Corporation is planning to send an important product information communication to customers to inform them about the new labeling statement.
Athorized Representative/Importer/Distributor:	Baxter AG
Report Source:	NCMDR
Source Ref. Number:	3588E1A055293
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Baxter Healthcare.pdf

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