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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 028 01 19 000
Date submitted: 1/10/2019
Manufacturer:Edwards Lifesciences
Device Type:Swan Ganz Thermodilution Catheters
Description:Catheters, Cardiac, Flotation Balloon, Pulmonary Artery, Thermal Dilution
Medical Device Identifier:Model Numbers: 131F7, 131F7P, 131VF7P, 151F7
Lot Numbers: 61176373, 61321254, 61176369, 61176314, 61176370, 61176367, 61176374, 61321241, 61311580
Reason of Field Safety Corrective Action:Lumens May Be Incorrectly Assembled
Remedy Action:To arrange for product return and to receive a returned goods authorization (RGA) number, contact the Edwards customer service department. Return any unused affected units to Edwards. Upon receipt of returned product, Edwards will provide your facility with replacement product.
Athorized Representative/Importer/Distributor:Arabian Health Care Supply Co. (AHCSC)
Report Source:NCMDR
Source Ref. Number:53A3FE2131246
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Edwards Lifesciences.pdf