Z-2189-2013Class II

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

Name: Z-2189-2013 "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure...
Creator: Edwards Lifesciences, LLC
Published: 2013-07-31
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2013-07-31 / Terminated / root cause: packaging

FDA source

Edwards Lifesciences, LLC began a recall of "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters on 2013-07-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2189-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Posted: 2013-09-11
Terminated: 2017-04-14
Recalling firm: Edwards Lifesciences LLC
Product: "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
Product code: DRS Transducer, Blood-Pressure, Extravascular
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Edwards Lifesciences initiated a US recall via an Urgent Product Recall letter dated July 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that an Edweards Lifesciences representative would come to their facility to retrieve the affected device. A device replacement would be provided to the customer. Customers were asked to complete the enclosed Confirmation Form and give it to the Edwards Lifesciences representative that will come to their facility. For customers with questions were instruct4ed to call Edwards Customers Service at 1-800-424-3278. For questions regarding this recall call 972-410-7100.
Quantity in commerce: 35 units
Distribution: Nationwide Distribution including MO and MI.
Product codes and lots: 595531157

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2189-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2189-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11

Product code DRS

K043065Class IIVigileo Arterial Pressure Cardiac Output/oximetry Monitor, Models Mihm1 and Mihm1pEdwards Lifesciences, LLC / cleared 2005-01-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)