At this time the manufacturer was unable to retrieve details regarding the device information.Therefore, possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.H3 other text : the device has not yet been returned to the manufacturer.
|
The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap/ bipap, and mechanical ventilator devices.The manufacturer received information alleging kidney disease/toxicity, eye, nose, skin and respiratory tract irritation, dizziness and/or headache, nausea/vomiting and inflammatory response.No other clinical information or medical interventions were reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
|