Device recall
Z-1058-2015: Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx)…
FDA device recall · Class II · Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Key facts
| Recall number (Z-number) | Z-1058-2015 |
|---|---|
| Recall event | 70239 |
| Product | Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It… |
| Product code | CBK |
| Recalling firm | Covidien LP (formerly Nellcor Puritan Bennett Inc.) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 6, 2016 |
| 510(k) numbers | K131252 |
| FEI number | 2936999 |
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