Device recall
Z-1374-2016: Custom Tubing Packs Custom tubing pack for oxygenators
FDA device recall · Class II · Maquet Cardiovascular Us Sales, Llc
Key facts
| Recall number (Z-number) | Z-1374-2016 |
|---|---|
| Recall event | 73390 |
| Product | Custom Tubing Packs Custom tubing pack for oxygenators |
| Product code | KFM |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2019 |
| 510(k) numbers | K080592 |
| FEI number | 3008355164 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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