Device recall
Z-0919-2021: Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698…
FDA device recall · Class II · Hardy Diagnostics
Key facts
| Recall number (Z-number) | Z-0919-2021 |
|---|---|
| Recall event | 87091 |
| Product | Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml |
| Product code | JSO |
| Recalling firm | Hardy Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 28, 2022 |
| 510(k) numbers | K964560 |
| FEI number | 2022807 |
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