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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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NCAR Recall

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Reference Number:	mdprc 038 06 11 000
Date submitted:	6/14/2011

Manufacturer:	Moog Inc
Device Type:	Curlin Ambulatory Infusion Pumps
Description:	Infusion Pumps, Patient-Controlled Analgesic.
Medical Device Identifier:	Model: 6000 CMS, Ref Nos: 360-1400, Lot Nos: All lots.
Reason of Field Safety Corrective Action:	Software Anomaly May Cause Pump Shutdown, which render the device inoperable until a recovery process is performed.
Remedy Action:	The manufacturer has recalled all Curlin 6000 CMS pumps. The distributor (B Braun) has issued an FSN advising users of the problem and is offering a free equivalent replacement pump.
Athorized Representative/Importer/Distributor:	N/A
Report Source:	NCAR
Source Ref. Number:	UK-2011-06-10-078
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	No Attachments

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