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 irritation and nosebleeds.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.Due to no device information being provided, the exact recall number is unknown, therefore the most likely recall number is reported on this report.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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