Device recall
Z-0979-2019: Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For…
FDA device recall · Class I · Cook Inc.
Key facts
| Recall number (Z-number) | Z-0979-2019 |
|---|---|
| Recall event | 82124 |
| Product | Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures. |
| Product code | DRC |
| Recalling firm | Cook Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 30, 2020 |
| FEI number | 1820334 |
At a glance
- None 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