Recall Z-2329-2015— Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Class I · Terminated
Class I FDA medical device recall by Covidien LP (formerly Nellcor Puritan Bennett Inc.), initiated 2015-07-16, terminated 2016-06-02. It names one FDA 510(k) clearance: K131252. Product: 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).. Reason: 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..
- Recalling firm
- Covidien LP (formerly Nellcor Puritan Bennett Inc.)
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-07-16
- Terminated
- 2016-06-02
- Firm location
- Boulder, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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).
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.