Device recall
Z-1070-2024: VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF…
FDA device recall · Class I · Ventec Life Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1070-2024 |
|---|---|
| Recall event | 93806 |
| Product | VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. |
| Product code | CBK |
| Recalling firm | Ventec Life Systems, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K162877 |
| FEI number | 3013095415 |
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