Device recall
Z-1042-2007: OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose…
FDA device recall · Class II · Lifescan Inc
Key facts
| Recall number (Z-number) | Z-1042-2007 |
|---|---|
| Recall event | 38016 |
| Product | OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07… |
| Product code | NBW |
| Recalling firm | Lifescan Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 15, 2008 |
| 510(k) numbers | K062195 |
| FEI number | 2939301 |
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