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 123 12 15 000
Date submitted:	12/29/2015

Manufacturer:	Acist Medical Systems
Device Type:	BT2000 and CPT2000 Manifold Kits
Description:	Manifold Kits
Medical Device Identifier:	two-products from certain lots: BT2000 (SKU 014613) and CPT2000 (SKU 014623)
Reason of Field Safety Corrective Action:	ACIST has received field reports related to ingress of air into the manifold;
Remedy Action:	If you possess unaffected lot numbers, complete the Medical Device Recall Form and continue to use as per ‘Instructions for Use’. If you possess affected lot numbers, complete the form and return this entire affected inventory to your distributor. Regardless, the Medical Device Recall Form must be completed. To order replacement product, use the normal ordering process with your Distributor.
Athorized Representative/Importer/Distributor:	Gulf Medical Co.
Report Source:	NCMDR
Source Ref. Number:	940E8813E4221
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	ACIST Recall Letter - EMEA indirect.pdf

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