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