FDA-Device2013-09-18Class II
"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
Edwards Lifesciences, LLC
Hazard
The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. There is no evidence available at this time that could validate the sterility of this incorrect packaging configuration.
Sold states
Nationwide Distribution including MO and MI.
Affected count
35 units
Manufactured in
1 Edwards Way, N/A, Irvine, CA, United States
Products
"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2189-2013Don't want to check this manually?
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