Reported Aug 26, 2015 · Terminated
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed…
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien LP (formerly Nellcor Puritan Bennett Inc.) · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214
Is this the product you have?
- Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
- Lot codes and dates
- PB980 Ventilator (980xxxxxxxx)
980U1ENDIUU980U1ENDIUUS980U3ENDIUU980U3ENDIUUS980N1ENDIUU980N1ENDIUUS980N3ENDIUU980N3ENDIUUS
- PB980 Ventilator (980xxxxxxxx)
- Amount recalled
- 657 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.
Using this product could cause serious injury, illness or death — stop using it now.
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