Device recall
Z-0076-2018: FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula…
FDA device recall · Class II · Sorin Group USA, Inc.
Key facts
| Recall number (Z-number) | Z-0076-2018 |
|---|---|
| Recall event | 78331 |
| Product | FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube… |
| Product code | DWF |
| Recalling firm | Sorin Group USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 17, 2018 |
| 510(k) numbers | K052081 |
| FEI number | 1718850 |
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