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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 015 04 13 000
Date submitted:
4/3/2013
Manufacturer:
Edwards Lifesciences
Device Type:
Edwards FloTrac Sensor
Description:
FloTrac Sensor
Medical Device Identifier:
model numbers: MHD6R and MHD8R
Reason of Field Safety Corrective Action:
some of the devices having been manufactured with a tubing length that does not meet specification (pressure tubing of 213 cm instead of 152 cm and vice versa)
Remedy Action:
A product replacement will be provided by Edwards Lifesciences to customers and distributors that would like to return those unused units listed as part of this notification as products become available.
Athorized Representative/Importer/Distributor:
Arabian Health Care Supply Co. (AHCSC), Riyadh, (01) 4747444
Report Source:
NCMDR
Source Ref. Number:
75D3873C7A285
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Edwards Lifesciences.pdf
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