Recall Z-2189-2013— Edwards Lifesciences, LLC

Name: FDA recall Z-2189-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-31

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2013-07-31, terminated 2017-04-14. It names one FDA 510(k) clearance: K043065. Product: "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.. Reason: 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..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Terminated: 2017-04-14
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K043065 — VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1PEdwards Lifesciences, LLC·cleared 2005-01-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.