Device recall
Z-2197-2013: Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite…
FDA device recall · Class II · Assuramed
Key facts
| Recall number (Z-number) | Z-2197-2013 |
|---|---|
| Recall event | 65980 |
| Product | Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous… |
| Product code | KHE |
| Recalling firm | Assuramed |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 27, 2017 |
| 510(k) numbers | K080812 |
| FEI number | 3009929723 |
At a glance
- 1–9 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