Recall Z-1919-2015— LifeHealth, LLC

Name: FDA recall Z-1919-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-29

Class II · Terminated

Class II FDA medical device recall by LifeHealth, LLC, initiated 2015-04-29, terminated 2015-10-20. It names one FDA 510(k) clearance: K945240. 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.. Reason: The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time..

Recalling firm: LifeHealth, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-04-29
Terminated: 2015-10-20
Firm location: Roseville, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K945240 — IRMA BLOOD ANALYSIS SYSTEMDiametrics Medical, Inc.·cleared 1995-01-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.