LifeHealth — Class II medical device recall Z-1919-2015
Terminated recall by LifeHealth, LLC, reported 2015-07-08. The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over t
| Recall number | Z-1919-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LifeHealth, LLC, Roseville, MN, United States |
| Recall initiated | 2015-04-29 |
| Classified | 2015-06-26 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2015-10-20 |
| Countries outside the US | AE, ID, LT, PE, PL |
| Quantity | 7 |
| Model numbers | 443914 |
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 for recall
The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1919-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.