LifeHealth, LLC: Medical Device Recall in 2015 - (Recall #: Z-1919-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 29, 2015

Date Posted: July 8, 2015

Recall Number: Z-1919-2015

Event ID: 71292

Reason for Recall:

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

Status: Terminated

Product Quantity: 7

Code Information:

44803, 44805, 44807, 44808, 44818, 44830, 44837

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated