Z-1919-2015 Class II Terminated
FDA device recall Z-1919-2015 was initiated by LifeHealth, LLC on April 29, 2015 and is designated Class II. Reason for recall: The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time. The recall status is terminated (terminated October 20, 2015). Affected quantity: 7.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2015
- Initiation Date
- April 29, 2015
- Termination Date
- October 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
Product Description
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.
Distribution Pattern
Worldwide distribution. US in the state of MI; INDONESIA, UNITED ARAB EMIRATES, LITHUANIA, POLAND, and PERU.
Code Information
44803, 44805, 44807, 44808, 44818, 44830, 44837