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.
FDA Recall Z-1919-2015 · Posted 2015-06-27
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Recalling FirmLifeHealth, LLC
Recall StatusTerminated
Product CodeCHL
Date Initiated2015-04-29
Date Terminated2015-10-20
Product Quantity7
Reason for Recall
The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution. US in the state of MI; INDONESIA, UNITED ARAB EMIRATES, LITHUANIA, POLAND, and PERU.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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