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.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 alleging cough, trouble sleeping, and irritation with no further details provided.The manufacturer was made aware of this complaint through a representative of the customer.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device has not yet been returned to the manufacturer for evaluation and there is no contact information to gain additional information on the device.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
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