FDA Says Datex-Ohmeda Recalls EVair Air Compressors Due To Formaldehyde Emissions Found In Specific Conditions As A Class I Recall
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The FDA has classified the recall of Datex-Ohmeda's EVair air compressors as a Class I recall due to the discovery of formaldehyde emissions under specific conditions. These compressors are used with Engstrom Carestation or Pro ventilators.
March 01, 2024 | 8:07 pm
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GE Healthcare, associated with Datex-Ohmeda, faces a Class I recall for EVair air compressors due to formaldehyde emissions, potentially impacting its reputation and product trust.
The Class I recall designation by the FDA indicates a situation where there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. This could lead to increased scrutiny on GE Healthcare's product safety, potentially affecting sales of the recalled product and related ventilator systems. The negative publicity could also impact the company's stock price in the short term as investors react to potential financial and reputational damage.
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