Device recall
Z-2394-2020: DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN…
FDA device recall · Class II · Defibtech, LLC
Key facts
| Recall number (Z-number) | Z-2394-2020 |
|---|---|
| Recall event | 85702 |
| Product | DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat. No. DCF-A2460EN DCF-A2463EN DCF-E2460DE DCF-E2460EN DCF-E2460FR DCF-E2460TH UDI 00815098020287, 00815098020317 Automated External Defibrillators (AED) are indicated for use on victims of sudden… |
| Product code | MKJ |
| Recalling firm | Defibtech, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 8, 2021 |
| FEI number | 3003521780 |
At a glance
- None 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