Edwards Lifesciences, LLC: Medical Device Recall in 2013 - (Recall #: Z-2189-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 31, 2013

Date Posted: September 18, 2013

Recall Number: Z-2189-2013

Event ID: 65984

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.

Status: Terminated

Product Quantity: 35 units

Code Information:

595531157

Distribution Pattern:

Nationwide Distribution including MO and MI.

Voluntary or Mandated:

Voluntary: Firm initiated