Device recall
Z-1919-2015: LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care…
FDA device recall · Class II · LifeHealth, LLC
Key facts
| Recall number (Z-number) | Z-1919-2015 |
|---|---|
| Recall event | 71292 |
| 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. |
| Product code | CHL |
| Recalling firm | LifeHealth, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 2015 |
| 510(k) numbers | K945240 |
| FEI number | 1000115726 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database