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 allegation of irritation (throat), bloody nose, and burning odor from the device.There was no report of serious patient harm or injury.Medical intervention was not specified.The manufacture's investigation is ongoing.A follow up report will be submitted when the manufacture's investigation is complete.
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There is no device information was provided.So, 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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