Recall Z-0774-2024— Datex-Ohmeda, Inc.
Class I · Ongoing
Class I FDA medical device recall by Datex-Ohmeda, Inc., initiated 2023-12-29. FDA's recall record names no specific 510(k) clearance for this event. Product: EVair air compressor, model numbers: M1230849 and M1230847. Reason: GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure..
- Recalling firm
- Datex-Ohmeda, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-12-29
- Firm location
- Madison, WI, United States
Product description
EVair air compressor, model numbers: M1230849 and M1230847
Reason for recall
GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE R860 or Engstr¿m Carestation/Pro ventilators, respectively. These elevated results were observed in preliminary testing that was conducted at an elevated room temperature of 40oC (104oF), at the lowest possible flow condition of 2 L/min (worstcase, minimum bias flow with no additional ventilation), and all of the gas being supplied from the compressor (i.e., FiO2 of 21% / no supplemental oxygen). GE HealthCare is continuing to evaluate the root cause for these elevated levels of formaldehyde. While these test conditions are not representative of typical clinical use conditions,GE HealthCare is taking this action to further reduce the potential for patient exposure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.