Reported Feb 7, 2024 · Ongoing
EVair air compressor, model numbers: M1230849 and M1230847
Datex-Ohmeda, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Datex-Ohmeda, Inc. · 3030 Ohmeda Dr · Madison, WI · 53718-6704
Is this the product you have?
- EVair air compressor
- model numbersM1230849 and M1230847
- Lot codes and dates
- UDI/DI 010084068210234621
- Serial Numbers
2,960 of 2,960 codes
CBRW00622CBRW00639CBRW00630CBRW00643CBRW00625CBRW00623CBRX04576CBRX04581CBRX04579CBRX04577CBRX04578CBRY00721CBRY00708CBRY00706CBRY00688CBRY00278CBRY02044CBRY02051CBRY02043CBRY02052CBRY02049CBRY02722CBRY02712CBRY02715CBRY02717CBRY02719CBRY02711CBRY02714CBRY02718CBRY02713CBRY02686CBRV02040CBRV02077CBRV02076CBRV02075CBRV02056CBRV02080CBRV02084CBRV02097CBRU02522CBRU02523CBRU03349CBRV00125CBRV00339CBRV02328CBRV02329CBRV02331CBRV02385CBRW00782CBRW00780CBRW00781CBRW00784CBRX01783CBRX01777CBRX01775CBRX01776CBRV02062CBRV02065CBRW00685CBRW00682
- Amount recalled
- 4032 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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