EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
Summary
The FDA issued a Class I for EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002 by Datex-Ohmeda, Inc.. 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 CARESCAP.
Details
Source
Device Recall
External ID
Z-0775-2024
Action Date
2024-02-07
Status
Ongoing
Category
device
Product Description
EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002
Lot/Code Info: UDI/DI ********, Serial Numbers: CBCS01269, CBCT02328, CBCT03050, CBCT02306, CBCT02301, CBCT02303, CBCT02302, CBCT02088, CBCT02309, CBCT02304, CBCU00717, CBCU00559
Quantity Affected: 12 units
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.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-29
Company
Madison, WI
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Datex-Ohmeda, Inc. has 29 FDA actions in our database, including 24 recalls and 5 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Datex-Ohmeda, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Datex-Ohmeda, Inc. have FDA actions?
Datex-Ohmeda, Inc. has 29 FDA actions in our database, including 24 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0775-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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