FDA recalls EVair 03 compressor models for elevated formaldehyde levels
FDA recalls EVair 03 air compressors (models 1609000, 1609002) for elevated formaldehyde when used with certain ventilators. The hazard was identified during preliminary testing under worst-case conditions: elevated room temperature (40°C) and minimal gas flow (2 L/min).
- Product
- EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
- Category
- Medical Device
- Distribution
- 0 states