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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65984

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 31, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Edwards Lifesciences, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2189-2013
Recall number
Z-2189-2013
Initiated
July 31, 2013
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
35 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrect packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

595531157

Distribution pattern

Nationwide Distribution including MO and MI.