Device recall
Z-0211-2015: Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide…
FDA device recall · Class II · Maquet Cardiovascular Us Sales, Llc
Key facts
| Recall number (Z-number) | Z-0211-2015 |
|---|---|
| Recall event | 69557 |
| Product | Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to… |
| Product code | DTQ |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 6, 2016 |
| 510(k) numbers | K102726 |
| FEI number | 3008355164 |
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