FDA Medical Device Recalls (openFDA)
LifeHealth, LLC: 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.
- Recall number
- Z-1919-2015
- Recalling firm
- LifeHealth, LLC
- 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.
- Status
- Terminated
- Initiated
- 2015-04-29
- Posted
- 2015-06-27
- Terminated
- 2015-10-20
- Reason
- The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were sent via e-mail a LifeHealth LLC " Urgent" letter dated April, 29th, 2015. The letter described the Purpose of this letter, Reason for the Voluntary Recall, Risk to Health, and Actions to be taken by the Customer. Advised consignees to immediately stop using the recalled product and return it to LifeHealth. Requested consignees to complete and return the Acknowledgement and Receipt Form.
- Quantity
- 7
- Distribution
- Worldwide distribution. US in the state of MI; INDONESIA, UNITED ARAB EMIRATES, LITHUANIA, POLAND, and PERU.
- Lot, serial or model codes
- 44803, 44805, 44807, 44808, 44818, 44830, 44837
- 510(k) numbers
- ["K945240"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 1000115726
- Firm city
- Roseville
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28