Device recall
Z-2028-2010: OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood…
FDA device recall · Class II · Lifescan Inc
Key facts
| Recall number (Z-number) | Z-2028-2010 |
|---|---|
| Recall event | 54565 |
| Product | OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in hospital and… |
| Product code | NBW |
| Recalling firm | Lifescan Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 8, 2010 |
| 510(k) numbers | K023194 |
| 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