Device recall
Z-1208-2018: Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-1208-2018 |
|---|---|
| Recall event | 79371 |
| Product | Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power… |
| Product code | CBK |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 10, 2020 |
| 510(k) numbers | K131252 |
| FEI number | 1219930 |
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