Home / Recalls / Covidien LP (formerly Nellcor Puritan Bennett Inc.) / Z-2329-2015

Z-2329-2015 Class I Terminated

Recalled by Covidien LP (formerly Nellcor Puritan Bennett Inc.) — Boulder, CO

FDA device recall Z-2329-2015 was initiated by Covidien LP (formerly Nellcor Puritan Bennett Inc.) on July 16, 2015 and is designated Class I. 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 respira… The recall status is terminated (terminated June 2, 2016). Affected quantity: 657 units.

Recall Details

Product Type: Devices
Report Date: August 26, 2015
Initiation Date: July 16, 2015
Termination Date: June 2, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 657 units

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.

Distribution Pattern

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, South Africa, Turkey, and Uruguay.

Code Information

PB980 Ventilator (980xxxxxxxx): 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, 980N3ENDIUUS

Other recalls by Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Z-1181-2016 Class II — Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intend (January 15, 2016)
Z-2267-2015 Class II — OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For cont (June 29, 2015)
Z-2268-2015 Class II — OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functio (June 29, 2015)
Z-1951-2015 Class I — Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard (May 8, 2015)
Z-1950-2015 Class I — Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Mode (May 8, 2015)
Z-1058-2015 Class II — Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), (January 12, 2015)