Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972, z-1973, and z-1974.H3 other text : device not returned to 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 patient is alleging of respiratory tract irritation, bronchial and respiratory distress and gastrointestinal issues.There was no serious patient harm or injury.At this time, no medical intervention has been reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
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