Device recall
Z-0004-2009: One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan…
FDA device recall · Class II · Lifescan Inc
Key facts
| Recall number (Z-number) | Z-0004-2009 |
|---|---|
| Recall event | 49413 |
| Product | One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and… |
| Product code | NBW |
| Recalling firm | Lifescan Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2010 |
| 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