"***Flo Trac Sensor Model MHD85***" Sterile — Class II medical device recall Z-2189-2013
Terminated recall by Edwards Lifesciences, LLC, reported 2013-09-18, distributed nationwide. The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to in
| Recall number | Z-2189-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2013-07-31 |
| Classified | 2013-09-11 |
| Reported by FDA | 2013-09-18 |
| Terminated | 2017-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 35 units |
| Reason classes | sterility |
Product
"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2189-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.