Device recall
Z-0497-2019: Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric…
FDA device recall · Class I · COVIDIEN LLC
Key facts
| Recall number (Z-number) | Z-0497-2019 |
|---|---|
| Recall event | 81167 |
| Product | Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal… |
| Product code | CBK |
| Recalling firm | COVIDIEN LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 1, 2021 |
| 510(k) numbers | K162738 |
| FEI number | 1282497 |
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