Device recall
Z-1352-2020: Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an…
FDA device recall · Class II · Breas Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1352-2020 |
|---|---|
| Recall event | 84828 |
| Product | Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during… |
| Product code | NOU |
| Recalling firm | Breas Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2020 |
| 510(k) numbers | K160481 |
| FEI number | 3010817335 |
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