Company: Covidien LP
Date of Enforcement Report 8/262015
Class l:
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). Recall Number Z-2329-2015
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/MANUFACTURER
Covidien LP (now part of Medtronic, formerly Nellcor Puritan Bennett, Inc), Boulder, CO on 7/16/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
657 units
DISTRIBUTION
Worldwide
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