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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01190-1
Product Name/Description Bunnell Life Pulse Patient Circuits (Used with Life Pulse High Frequency Ventilator)

Manufactured after 19-12-2012

Lot Numbers: 12C092, 12E211, 12H330, 12C102, 12E224, 12H349, 12C115, 12F241, 12I362, 12C125, 12F254, 12I371, 12C136, 12F271, 12I397, 12D159, 12G279, 12J413, 12D172, 12G290, 12J430, 12D189, 12G307, 12J448, 12E204, 12G321, 12K457, 12K471

ARTG number for the Ventilator: 179402
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 4/01/2013
Responsible Entity AHC Solutions Pty Ltd
Reason/Issue The heater wire insulation can melt, causing a short which creates sparking and smoke close to the humidifier cartridge.
Recall Action Recall
Recall Action Instructions Unaffected replacement circuits are not available at this time. Each user should consider the likelihood and severity of the potential risks of using the affected circuits, as well as the medical necessity of using High Frequency “Jet” Ventilation, to determine whether it would be in their patients’ best interests to use the affected circuits or not. If users have other options for High Frequency “Jet” Ventilation, the affected units can be returned to AHC Solutions for credit to be issued.
Contact Information 02 9980 9669 - AHC Solutions