Device recall
Z-1258-2011: FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood…
FDA device recall · Class II · Abbott Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-1258-2011 |
|---|---|
| Recall event | 51399 |
| Product | FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, for use with FreeStyle and FreeStyle Lite Test Strips respectively, 100 count, manufactured by Abbott Diabetes Care, Alameda, CA. Product is used with FreeStyle and FreeStyle Lite… |
| Product code | NBW |
| Recalling firm | Abbott Diabetes Care, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 15, 2011 |
| 510(k) numbers | K051839 |
| FEI number | 3002803444 |
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