Device recall
Z-1477-2017: C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller…
FDA device recall · Class II · C2 Therapeutics, Inc.
Key facts
| Recall number (Z-number) | Z-1477-2017 |
|---|---|
| Recall event | 76358 |
| Product | C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2… |
| Product code | GEH |
| Recalling firm | C2 Therapeutics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 13, 2017 |
| 510(k) numbers | K131523, K152329, K161202 |
| FEI number | 3008780134 |
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