Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
"***Flo Trac Sensor Model MHD85***" Sterile Recalled by Edwards Lifesciences, LLC Due to The Edwards Lifesciences FloTrac Sensor is being recalled...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Edwards Lifesciences, LLC directly.
Affected Products
"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
Quantity: 35 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Edwards Lifesciences, LLC
Edwards Lifesciences, LLC has 94 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report