FDA Medical Device Recalls (openFDA)
Edwards Lifesciences, LLC: "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
- Recall number
- Z-2189-2013
- Recalling firm
- Edwards Lifesciences, LLC
- Product
- "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
- Status
- Terminated
- Initiated
- 2013-07-31
- Posted
- 2013-09-11
- Terminated
- 2017-04-14
- 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.
- 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
- 35 units
- Distribution
- Nationwide Distribution including MO and MI.
- Lot, serial or model codes
- 595531157
- 510(k) numbers
- ["K043065"]
- PMA numbers
- not on file
- Product code
- DRS
- Firm FEI
- 2015691
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28