Device recall
Z-2277-2015: Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged…
FDA device recall · Class II · Hardy Diagnostics
Key facts
| Recall number (Z-number) | Z-2277-2015 |
|---|---|
| Recall event | 71602 |
| Product | Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE). |
| Product code | JSO |
| Recalling firm | Hardy Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 11, 2015 |
| FEI number | 2022807 |
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