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 Insight

This FDA Devices action (record #Z-2329-2015) was formally reported on August 26, 2015, with the manufacturer initiating the action on July 16, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Covidien LP (formerly Nellcor Puritan Bennett Inc.) is listed as the recalling firm, operating out of Boulder, CO. Federal records list the affected scope as 657 units.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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, Moro…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.