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).
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which warrants a minimum severity score of 4 per the classification rules. No deaths or reported illnesses have been documented; the elevated formaldehyde levels were detected only in preliminary testing under non-typical clinical conditions.
Plain-English summary
GE HealthCare has recalled the EVair 03 and Jun-air medical air compressors (models 1609000 and 1609002) in response to elevated formaldehyde levels detected during testing. Twelve units of these compressors are affected worldwide.
The compressors can produce elevated levels of formaldehyde when used with specific ventilators: the CARESCAPE R860 or Engström Carestation/Pro models. These elevated levels were observed during preliminary laboratory testing conducted at elevated room temperature (40°C / 104°F) and at minimal flow conditions (2 L/min), using only gas from the compressor without supplemental oxygen. GE HealthCare notes that these test conditions do not represent typical clinical use conditions but is taking this recall action to reduce potential patient exposure.
Patients and healthcare facilities using these air compressor models should verify their equipment serial numbers. The recalled serial numbers are: CBCS01269, CBCT02328, CBCT03050, CBCT02306, CBCT02301, CBCT02303, CBCT02302, CBCT02088, CBCT02309, CBCT02304, CBCU00717, and CBCU00559.
The recalled product
- Product
- EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
- Manufacturer
- Datex-Ohmeda, Inc.
- Hazard
- formaldehyde-exposure
- chemical-inhalation-hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- UDI/DI ********
- Serial Numbers: CBCS01269
- CBCT02328
- CBCT03050
- CBCT02306
- CBCT02301
- CBCT02303
- CBCT02302
- CBCT02088
- CBCT02309
- CBCT02304
- CBCU00717
- CBCU00559
Distribution
Distribution scope not specified by the agency.
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