Device recall
Z-0112-2015: Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a…
FDA device recall · Class I · Nellcor Puritan Bennett Inc. (dba Covidien LP)
Key facts
| Recall number (Z-number) | Z-0112-2015 |
|---|---|
| Recall event | 69320 |
| Product | Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations. |
| Product code | CBK |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 2, 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