Reported Jul 8, 2015 · Terminated

LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of…

LifeHealth, LLC

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: LifeHealth, LLC · 2656 Patton Rd · Roseville, MN · 55113-1136

Is this the product you have?

  • LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood
  • These analytes includespO2, pCO2, pH, iCa, Na, K and Cl
Lot codes and dates
    • 44803
    • 44805
    • 44807
    • 44808
    • 44818
    • 44830
    • 44837
Amount recalled
7

Where it was sold

Why it was recalled

The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.

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 20, 2015 · Data as of Sep 19, 5:29 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.