Device recall
Z-1561-2021: Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package…
FDA device recall · Class II · Remel Inc
Key facts
| Recall number (Z-number) | Z-1561-2021 |
|---|---|
| Recall event | 87830 |
| Product | Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures. |
| Product code | JSO |
| Recalling firm | Remel Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2023 |
| 510(k) numbers | K972359 |
| FEI number | 1924669 |
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