Device recall
Z-1460-2020: Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite…
FDA device recall · Class II · Braemar Manufacturing, LLC
Key facts
| Recall number (Z-number) | Z-1460-2020 |
|---|---|
| Recall event | 84883 |
| Product | Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only |
| Product code | MWJ |
| Recalling firm | Braemar Manufacturing, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 27, 2022 |
| 510(k) numbers | K071733 |
| FEI number | 1000520785 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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