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

Recall date

April 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1919-2015

FDA classification

Class II

Brand / firm

LifeHealth, LLC

Sold / distributed

Worldwide distribution. US in the state of MI; INDONESIA, UNITED ARAB EMIRATES, LITHUANIA, POLAND, and PERU.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.