Device recall
Z-1844-2014: Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is…
FDA device recall · Class II · Nellcor Puritan Bennett Inc. (dba Covidien LP)
Key facts
| Recall number (Z-number) | Z-1844-2014 |
|---|---|
| Recall event | 68444 |
| Product | Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare… |
| Product code | CBK |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2016 |
| 510(k) numbers | K970460 |
| 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