Device recall
Z-2070-2020: NRG RF Transseptal Kit; Model No.s: NTK-710-8545, NTK-710-8555, NTK-711-8545…
FDA device recall · Class II · Baylis Medical Company Inc.
Key facts
| Recall number (Z-number) | Z-2070-2020 |
|---|---|
| Recall event | 85353 |
| Product | NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-8555, NTK-711-8590, NTK-P711-8545, NTK-P711-8555, NTK-710-8545S, NTK-710-8555S, NTK-711-8545S, NTK-711-8555S, NTK-710-8545N, NTK-711-8545N and NTK-711-8555N. |
| Product code | DYB |
| Recalling firm | Baylis Medical Company Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2021 |
| 510(k) numbers | K102948 |
| FEI number | 3000157372 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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