Device recall
Z-1018-2016: CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group…
FDA device recall · Class III · Sorin Group USA, Inc.
Key facts
| Recall number (Z-number) | Z-1018-2016 |
|---|---|
| Recall event | 73126 |
| Product | CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring… |
| Product code | DWF |
| Recalling firm | Sorin Group USA, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 24, 2016 |
| 510(k) numbers | K881330 |
| 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