Device recall
Z-0021-2020: Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002…
FDA device recall · Class I · Galemed Corporation
Key facts
| Recall number (Z-number) | Z-0021-2020 |
|---|---|
| Recall event | 83318 |
| Product | Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559 |
| Product code | BZD |
| Recalling firm | Galemed Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 20, 2024 |
| 510(k) numbers | K110383 |
| FEI number | 3003319165 |
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