Reported Feb 25, 2015 · Terminated

Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable…

Pulsion Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Pulsion Medical Inc · 3781 Attucks Dr · Powell, OH · 43065-6080

Is this the product you have?

  • Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package
  • Product UsageMeasures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis
Lot codes and dates
    • Model Number PV8810US
    • Lot # 14AK20 and 14EK20
Amount recalled
90 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 2, 2015 · Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.