Device recall
Z-0109-2022: Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the…
FDA device recall · Class II · Draeger Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0109-2022 |
|---|---|
| Recall event | 88635 |
| Product | Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400 |
| Product code | CBK |
| Recalling firm | Draeger Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K093632 |
| FEI number | 2517967 |
At a glance
- 1–9 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