Device recall
Z-1903-2013: Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435…
FDA device recall · Class I · Nova Biomedical Corporation
Key facts
| Recall number (Z-number) | Z-1903-2013 |
|---|---|
| Recall event | 65617 |
| Product | Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the… |
| Product code | NBW |
| Recalling firm | Nova Biomedical Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 1, 2017 |
| 510(k) numbers | K091547 |
| FEI number | 1219029 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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