Device recall
Z-2769-2020: Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use…
FDA device recall · Class II · Covidien Llc
Key facts
| Recall number (Z-number) | Z-2769-2020 |
|---|---|
| Recall event | 86001 |
| Product | Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to… |
| Product code | FCG |
| Recalling firm | Covidien Llc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K180037 |
| FEI number | 1282497 |
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