Device recall
Z-0650-2014: Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate…
FDA device recall · Class II · Nova Biomedical Corporation
Key facts
| Recall number (Z-number) | Z-0650-2014 |
|---|---|
| Recall event | 66398 |
| Product | Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole… |
| Product code | CGA |
| Recalling firm | Nova Biomedical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 24, 2014 |
| 510(k) numbers | K060345, K063821, K070068 |
| FEI number | 1219029 |
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