Breas Medical, Inc. has recalled 8,298 Vivo 45 LS pressure and volume ventilators because they may emit elevated levels of formaldehyde into the patient's breathing airpath during the first seven days of use. This recall affects Model/Catalog Number 230000 (including sub-versions 230016 and 230216) and includes all lots manufactured up to May 30, 2024. These devices are used to provide continuous or intermittent breathing support for patients requiring mechanical ventilation.
Under specific conditions during the first week of use, the device's internal components can release formaldehyde gas into the air the patient breathes, which poses a risk of respiratory irritation or other adverse health effects.
Manufacturer notification and professional consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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