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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69782

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

Open FDA event record

Event summary

Timeline bucket
November 04, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Pulsion Medical Inc

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

Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.

Z-1121-2015
Recall number
Z-1121-2015
Initiated
November 04, 2014
Classification
Class II
Status
Terminated
Recalling firm
Pulsion Medical Inc
Quantity
90 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Internal testing and investigation of the packaging revealed cracks and holes in primary packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Internal testing and investigation of the packaging revealed cracks and holes in primary packaging

Code information

Model Number PV8810US; Lot # 14AK20 and 14EK20

Distribution pattern

US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.