LifeHealth IRMA TRUPoint 443914 Recalled for Barometric Pressure Drift
LifeHealth is recalling seven IRMA TRUPoint 443914 devices because their barometric pressure measurements drift over time, potentially affecting critical care analyte results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
LifeHealth, LLC is recalling seven units of the IRMA TRUPoint model 443914, a medical device used in point-of-care settings for the in vitro measurement of critical care analytes in human whole blood. The affected devices are identified by serial numbers 44803, 44805, 44807, 44808, 44818, 44830, and 44837.
The recall is due to a defect where the barometric pressure measurement output of the device drifts over time. This device is used to measure analytes including pO2, pCO2, pH, iCa, Na, K, and Cl.
The affected devices were distributed worldwide, including in the United States (Michigan), Indonesia, the United Arab Emirates, Lithuania, Poland, and Peru. Users should contact LifeHealth, LLC for further instructions regarding the recall.
The recalled product
- 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
- LifeHealth, LLC
- Hazard
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 44803
- 44805
- 44807
- 44808
- 44818
- 44830
- 44837
Distribution
Distributed in 1 state:
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