Datex-Ohmeda Inc, part of GE HealthCare, recently recalled its EVair and Jun-air compressors due to elevated levels of formaldehyde emissions found at high temperatures and low gas flow conditions when these compressors are used with the CARESCAPE R860 or Engstrom Carestation or Pro ventilators.
The FDA has now classified the recall as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The use of the affected air compressor may also cause airway irritation or inflammation that could potentially lead to airway hyperresponsiveness in newborns or infants.
Recalled Product
- Product names:
- EVair air compressors (model numbers M1230849, M1230847)
- EVair-03 air compressors (Jun-air; model numbers 1609000, 1609002)
- EvAir CPRSR Kits (model numbers M1230849, M1230847)
- Product codes: See recall database entry
- Distribution dates: Sept 1, 2013, to Nov 16, 2023
- Devices recalled in the US: 511
- Date initiated by firm: Nov 15, 2023
The EVair and Jun-air compressors are optional ventilator accessories intended to provide an alternative source of airflow for patient support for use in clinical scenarios where wall air is unavailable.
The EVair medical air compressor is intended to be connected to a Datex-Ohmeda Inc critical care ventilator, CARESCAPE R860, as a supply of compressed medical breathing air. The ventilator must be operated with at least one additional supply of compressed medical breathing air or oxygen beside the EVair.
The EVair 03 compressor is intended for use as an optional accessory to Datex-Ohmeda critical care ventilators, Engstrom Carestation/Pro, as a breathable compressed air supply. If the compressor is the primary air supply to the system, ensure that a compressed oxygen supply is also connected.
There have been no reported injuries or reports of death associated with this issue.
Customers in the US with questions about this recall should contact GE HealthCare Service at 1-800-437-1171.
