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.The manufacturer received information from the legal department with the patient alleging eye irritation, skin irritation, respiratory tract irritation, dizziness and or headache, hypersensitivity, nausea/vomiting, asthma, kidney disease/toxicity, and lung disease.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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