Device recall
Z-1458-2010: Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit…
FDA device recall · Class II · Abbott Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-1458-2010 |
|---|---|
| Recall event | 52635 |
| Product | Freestyle Navigator Continuous Glucose Monitor System, Clinical System Kit, Packaging. Abbott Item Number: PRT 03415-010, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes… |
| Product code | MDS |
| Recalling firm | Abbott Diabetes Care, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2011 |
| PMA numbers | P050020 |
| FEI number | 3002803444 |
At a glance
- None Linked 510(k)s
- 10–99 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