Recall Z-1919-2015 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
| Date | Jun 27, 2015 (initiated Apr 29, 2015) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945240 | IRMA BLOOD ANALYSIS SYSTEM Diametrics Medical, Inc., Jan 5, 1995 |