Device recall
Z-1165-2007: One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT…
FDA device recall · Class II · Lifescan Inc
Key facts
| Recall number (Z-number) | Z-1165-2007 |
|---|---|
| Recall event | 38035 |
| Product | One Touch SureSoft Lancing Device in carton. Part Number 021-140-01, aka OT SureSoft Hospital, Gentle 200 |
| Product code | FMK |
| Recalling firm | Lifescan Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 3, 2007 |
| FEI number | 2939301 |
At a glance
- None Linked 510(k)s
- 1–9 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