Drug recall
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
FDA recall event 69324 · Class I · Nellcor Puritan Bennett Inc. (dba Covidien LP)
Key facts
| Event ID | 69324 |
|---|---|
| Recall numbers | Z-0180-2015 |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Product type | Devices |
| Products | Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor. |
| Initiation date | Oct 1, 2014 |
| Report date | Dec 17, 2014 |
| Termination date | Jul 1, 2016 |
| City | Boulder |
| State | CO |
| Country | United States |
| FEI number | 2936999 |
At a glance
- 1–9 Products in this recall
- None 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: