Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalls Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed fo…

Recall date

July 16, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2329-2015

FDA classification

Class I

Brand / firm

Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Sold / distributed

Worldwide Distribution-US (nationwide) and the countries of Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuwait, Lebanon, Morocco, Mexico, Panama, Peru, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, Sout…

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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).