Due to the manufacturer not receiving the device information, the following are possible recall z numbers: z-1972-2021, z-1974-2021, and z-1973-2021.H3 other text device not returned to 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 patient has alleged eye irritation, nose irritation, respiratory tract irritation, nausea / vomiting, reduced cardiopulmonary reserve, death, copd.Medical intervention was not specified.The device has not yet been returned to the manufacturer for investigation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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