—#121142

Product

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

FDA product code: DRS — Transducer, Blood-Pressure, Extravascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K043065
Affected lot / code info: 595531157

Why it was 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.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern: Nationwide Distribution including MO and MI.

Timeline

Recall initiated: 2013-07-31
Posted by FDA: 2013-09-11
Terminated: 2017-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121142. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.