Device recall
Z-0393-2017: NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers…
FDA device recall · Class II · Baylis Medical Corp *
Key facts
| Recall number (Z-number) | Z-0393-2017 |
|---|---|
| Recall event | 75474 |
| Product | NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF-71-C0. The NRG Transseptal Needle is packaged onto a thermoformed tray with two lids, which is… |
| Product code | DXF |
| Recalling firm | Baylis Medical Corp * |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 10, 2017 |
| 510(k) numbers | K073326 |
| FEI number | 3005241199 |
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