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

FDA device recall Z-2189-2013 · posted 2013-09-11 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, LLC

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.

Action taken

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.

Root cause

Packaging process control

Status

Terminated

Product code

DRS

Quantity affected

35 units

Distribution

Nationwide Distribution including MO and MI.

Date initiated

2013-07-31

Date posted

2013-09-11

Date terminated

2017-04-14

Location

Irvine, CA

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