Drug recall
Puritan Bennett 980 Series Ventilator
FDA recall event 89820 · Class I · Medtronic formerly Covidien
Key facts
| Event ID | 89820 |
|---|---|
| Recall numbers | Z-0966-2022 |
| Recalling firm | Medtronic formerly Covidien |
| Product type | Devices |
| Products | Puritan Bennett 980 Series Ventilator |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of… |
| Initiation date | Mar 25, 2022 |
| Report date | May 4, 2022 |
| City | Galway |
| Country | Ireland |
| FEI number | 3002807850 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: