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 : the device has not been returned to the manufacturer for analysis.
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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.Per the legal department, there is an allegation of dizziness and/or headaches, nausea/vomiting, lung disease, and death related to the unspecified device's sound abatement foam becoming degraded.The reporter did not report the patient to receive any medical intervention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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