Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.H3 other text : device not returned to the manufacturer.
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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 eye irritation, nose irritation, skin irritation, respiratory tract irritation, new or worsening of asthma, inflammatory response, continuous postnasal drip, and ear infections.The manufacturer was made aware of this complaint through a representative of the customer.Medical intervention was not specified.The device has not yet been returned to the manufacturer for evaluation and there is no contact information to gain additional information on the device.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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