Device recall
Z-1675-2014: Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-1675-2014 |
|---|---|
| Recall event | 68159 |
| Product | Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors. It provides users with a secondary means to verify the monitor's PtO2 state-of-calibration (but does not provide calibration) when needed by providing a specific electrical signal to the… |
| Product code | GWM |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 24, 2014 |
| 510(k) numbers | K131184 |
| FEI number | 3003418325 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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