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, inflammatory response, cancer, breast cancer.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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Due to the manufacturer not receiving the device information, the following are possible recall z numbers: z-1972-2021, z-1974-2021, z-1973-2021.H3 other text : device not returned to manufacturer.
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