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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 061 11 17 000
Date submitted: 11/19/2017
Manufacturer:3M Health Care Ltd
Device Type:Bair Hugger Temperature Monitoring Sensors
Description:Monitors, Physiologic, Temperature
Medical Device Identifier:Model No. 36000; Lot Nos.: 17230, 17233, 17234, 17241 Formerly known as SpotOn Temperature Monitoring Sensors
Reason of Field Safety Corrective Action:Programming Translation Error May Lead to Temperature Readout Lower than Actual Patient Temperature
Remedy Action:Identify, isolate, and discard any affected product in your inventory. If you have affected product, verify that you received the October 17, 2017, Urgent Medical Device Recall letter and/or the October 19, 2017, Field Safety Notice letter and reply form from 3M. Regardless of whether you have affected product, complete the reply form and return it to 3M using the instructions on the form. Upon receipt of the form, 3M will provide your facility with replacement product, if applicable. Notify all relevant personnel at your facility of the information in the letter(s), and forward a copy of the letter(s) to any facility to which you have further distributed affected product.
Athorized Representative/Importer/Distributor:3M company
Report Source:NCMDR
Source Ref. Number:AFD3FAE3693C8
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: 3M Health Care.pdf