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Covidien LP (formerly Nellcor Puritan Bennett Inc.) Recalls
7 recalls on record · February 11, 2015 to March 23, 2016 · Medical Devices
Recalls by year
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 23, 2016Medical DevicesFDA
Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalls Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for
Hazard: Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field corrective action notice for two issues on all models of Puritan Bennett 980 (PB980) ventilator.
August 26, 2015Medical DevicesFDA
Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalls Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed
Hazard: 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.
August 5, 2015Medical DevicesFDA
Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalls OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) an
Hazard: Potential missing segments on the display that can result in misinterpretation of data.
August 5, 2015Medical DevicesFDA
Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalls OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of funct
Hazard: Potential missing segments on the display that can result in misinterpretation of data.
July 15, 2015Medical DevicesFDA
Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalls Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing t
Hazard: Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.
July 15, 2015Medical DevicesFDA
Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalls Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers: 2.5NEF,3.0NEF,3.5NEF,4.0NEF,4
Hazard: Reports where patients who recently switched from the current Shiley Neonatal and Pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.
February 11, 2015Medical DevicesFDA
Covidien LP (formerly Nellcor Puritan Bennett Inc.) recalls Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilat
Hazard: Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.