There is no device information was provided.So, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.H3 other text : device not returned to the 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 manufacturer received information an allegations of eye irritation nose irritation, skin irritation, respiratory tract irritation, dizziness and/or headache, nausea/vomiting, heavy phlegm and mucus build up, chest pain, heart burn, shortness of breath, nasal and mouth sores.The manufacturer was made aware of this complaint through a representative of the customer.There was no report of serious patient harm or injury.Medical intervention was not specified.The manufacture's investigation is ongoing.A follow up report will be submitted when the manufacture's investigation is complete.
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