Breas initiates correction
By HME News Staff
Updated 9:52 AM CDT, Mon August 12, 2024
NORTH BILLERICA, Mass. – Breas Medical has initiated a nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing of the ventilator identified the potential for short-term elevated levels of formaldehyde exposure to users under specific conditions, the company says. Short-term formaldehyde emissions may lead to adverse pulmonary or neurological effects, such as the potential for transient, reversible airway irritation or inflammation that could lead to airway hyperresponsiveness, such as asthma in small pediatric patients, resulting in additional medical intervention, it says. The devices subject to the correction were manufactured from Feb. 4, 2021, to July 1, 2024, and distributed from Feb. 12, 2021, to July 24, 2024. The correction reduces the maximum room air temperature for operation of the device from 104 degrees Fahrenheit to 86 degrees Fahrenheit, and requires new devices shipped through July 24, 2024, to be pre-run for 14 days prior to use. Breas says it has not received any reports of patient injury or adverse effects related to potential exposure to formaldehyde from the use of the Vivo 45 LS to date. The company is notifying its distributors and commercial customers in the U.S. of the correction by email or phone. Breas has notified the U.S. Food and Drug Administration of the correction.
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