Device recall
Z-2531-2023: remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B…
FDA device recall · Class II · Remel, Inc
Key facts
| Recall number (Z-number) | Z-2531-2023 |
|---|---|
| Recall event | 92880 |
| Product | remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora |
| Product code | JSD |
| Recalling firm | Remel, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K871447 |
| FEI number | 1924669 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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