Device recall
Z-1937-2009: EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton…
FDA device recall · Class II · Oak Tree International Holdings, LLC, Inc.
Key facts
| Recall number (Z-number) | Z-1937-2009 |
|---|---|
| Recall event | 52352 |
| Product | EASYMax N. Self-Monitoring Blood Glucose System, distributed in cardboard carton kits. Each kit contains the following components: Blood Glucose Meter; Test Strip x 10 ct.; Normal Control Solution; Carrying Case; Alkaline Battery x 2 ct.; Lancets x 5 ct.; Lancing Device; AST Lancing Device Cap… |
| Product code | NBW |
| Recalling firm | Oak Tree International Holdings, LLC, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2012 |
| 510(k) numbers | K083099 |
| FEI number | 3007644653 |
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