Device recall
Z-0425-2021: Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on…
FDA device recall · Class II · Covidien Llc
Key facts
| Recall number (Z-number) | Z-0425-2021 |
|---|---|
| Recall event | 86643 |
| Product | Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation SKU: 980X1ENDIUU 980X1ENDIUU 980X3FRAIQC 980X3DEDRAC 980X3ENNISB 980X3NLDRAC 980X3PLDIPC 980X3ESDIEC… |
| Product code | CBK |
| Recalling firm | Covidien Llc |
| Recall class | Class II |
| Status | Open, Classified |
| 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