Bunnell, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 51 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Bunnell, Inc. makes
Bunnell, Inc. manufactures the Life Pulse High Frequency Ventilator, a medical device designed for mechanical ventilation in critical care settings, utilizing high-frequency oscillatory techniques to support respiratory function.
The company’s portfolio is regulated under FDA Class III requirements and listed in the FDA’s Premarket Approval (PMA) registry, reflecting its designation as a high-risk device. The manufacturer is based in the United States.
Catalogue
Life Pulse High Frequency Ventilator Ref P850064
PMA PMA
FDA recalls
FDA recall records list 5 recalls initiated by Bunnell, Inc., the earliest on 2005-04-04 and the most recent on 2022-11-02. By recorded status: 1 ongoing and 4 terminated. The reasons filed fall into these groups: software or firmware, packaging, electrical or power and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 2 Nov 2022 Z-0371-2023 Class II Ongoing Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect normal ventilator performance, which may lead to hypercarbia, hypoxia, and gas trapping.
Full distribution text
- 2 Nov 2022 Z-0371-2023 Class II Ongoing Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect normal ventilator performance, which may lead to hypercarbia, hypoxia, and gas trapping.
2012
- 19 Nov 2012 Z-0514-2013 Class I Terminated Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunnell is recalling all lots of circuits distributed between March 12, 2012 and November 30, 2012.
Full distribution text
- 19 Nov 2012 Z-0514-2013 Class I Terminated Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunnell is recalling all lots of circuits distributed between March 12, 2012 and November 30, 2012.
2010
- 25 Oct 2010 Z-0901-2011 Unclassified (pre-2012) Terminated Product software coding error may compromise patient safety.
- 25 Oct 2010 Z-0902-2011 Unclassified (pre-2012) Terminated Product software coding error may compromise patient safety.
2005
- 4 Apr 2005 Z-0893-06 Unclassified (pre-2012) Terminated Potential loss of air flow or change in cycling of the ventilator. Valve Drive Regulator Board may not function properly at elevated temperatures. The increase in temperature could cause a reduction of power, causing the solenoid in the valve to function sporadically.
Frequently asked questions
How many devices does Bunnell, Inc. have in the registry?
The registry currently lists 1 device for Bunnell, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bunnell, Inc.'s devices?
Among its 1 most recently registered device, Bunnell, Inc. has devices listed in FDA PMA (1 device).
What risk classes do Bunnell, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Bunnell, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Bunnell, Inc.?
FDA recall records list 5 recalls initiated by Bunnell, Inc., the most recent initiated on 2022-11-02. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Bunnell, Inc. in the registry?
The most recently registered devices listed for Bunnell, Inc. include LIFE PULSE HIGH FREQUENCY VENTILATOR.