Device recall
Z-1603-2020: Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
FDA device recall · Class II · Maquet Cardiovascular Us Sales, Llc
Key facts
| Recall number (Z-number) | Z-1603-2020 |
|---|---|
| Recall event | 85104 |
| Product | Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 |
| Product code | DRE |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 18, 2022 |
| 510(k) numbers | K081940 |
| 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