Device recall
Z-2871-2017: Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product…
FDA device recall · Class II · Sorin Group USA, Inc.
Key facts
| Recall number (Z-number) | Z-2871-2017 |
|---|---|
| Recall event | 77699 |
| Product | Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. |
| Product code | DWF |
| Recalling firm | Sorin Group USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 9, 2023 |
| 510(k) numbers | K943934 |
| 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