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LifeHealth, LLC recalls LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of vari
Recalled July 8, 2015 · FDA recall Z-1919-2015 · LifeHealth
Hazard
The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time. · FDA Class II
Units
7
Sold at
Worldwide distribution. US in the state of MI; INDONESIA, UNITED ARAB EMIRATES, LITHUANIA, POLAND, and PERU.
Description
The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.
Product
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 includes: pO2, pCO2, pH, iCa, Na, K and Cl.
Manufacturer(s)
LifeHealth, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →