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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 110 12 18 000
Date submitted:	12/25/2018

Manufacturer:	Yuyao Yufeng Medical Equipment Co., Ltd.
Device Type:	Oxygen Regulator
Description:	Oxygen Regulator
Medical Device Identifier:	Model No.: YF-86-A
Reason of Field Safety Corrective Action:	Yuyao Yufeng Medical Equipment Co., Ltd is issuing a Field Safety Notice to advise users of an update to the Instructions For Use (IFU) for Oxygen Regulator YF-86-A per the enclosed attachment (Attachment 1). This information will be included in the IFU & Cartons of all future units distributed by Yufeng Medical. This IFU update provides clear information about cleaning & disinfection method for oxygen regulator YF-86-A.
Remedy Action:	RECOMMENDED CLEANING & DISINFECTION METHOD Clean using a pH neutral disinfectant for wiping clean. Wipe with a damp cloth and dry with paper towel to remove residue.Do not wipe the contact areas of the inlet and outlet connectors. Use high temperature disinfection for the humidifier bottles , and the degree is 121 ℃. The cap can’t be autoclavable
Athorized Representative/Importer/Distributor:	Al-Asemah Medical Company
Report Source:	NCMDR
Source Ref. Number:	BBBFF1146F2EE
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Yuyao Yufeng Medical Equipment Co., Ltd.pdf

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