OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 034 04 18 000
Date submitted: 4/8/2018
Manufacturer:Shanghai Kinmed Import & Export Co., Ltd
Device Type:Kinmed Aerosol Mask
Description:Aerosol Mask
Medical Device Identifier:1)Adult elongated
-Catalog Number: KM‐KS028
-Lot Number: 20170428
-expiration Date: 20220427

2)Pediatric elongated:
-Catalog Number: KM‐KS028
-Lot Number: 20170428
-expiration Date: 20220427
Reason of Field Safety Corrective Action:After The Aerosol Mask is connected to the compressed air source, Partial nebulizers cannot be nebulized or partial nebulization
Remedy Action:Actions to be taken by the customer:
-Before clinical use, please check whether the nebulization effect is normal;
- It is suggested that when the clinic is used, the gas flow rate should be controlled at 4-6L/min according to the atomization condition of the drug.
- If it is a nebulizer cannot be nebulized or partially nebulized, it is forbidden to use it. Specific contents of the recall measures:
-Recall 15,000pcs defective products immediately and unconditionally, compensate the customer with the same amount of product at the same time, to ensure the normal supply of the products and meet customer demand. The cost of the recall and the freight charges are all bear by our company, customer don’t need to bear any fee.
-The implementation plan of the recall measures: Starting from this notice, all products that have been sent to the hospital and warehouse inventory are stop using and recall to the Chinese factory to process. The related costs are bear by the factory.
-After receiving this notice, Please communicate with us in time, to ensure the recall of all products are smoothly, and avoid to cause a wide range of negative effects.
Athorized Representative/Importer/Distributor:Salehiya Trading Est.
Report Source:NCMDR
Source Ref. Number:8D2BAA8C46234
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Shanghai Kinmed Import & Export Co., Ltd.pdf