Vivo 45 LS Ventilator Recall: Potential Formaldehyde Emission Risk
Breas Medical is recalling the Vivo 45 LS ventilator due to potential elevated formaldehyde emissions into the patient breathing airpath under specific conditions.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity of 4 per the rubric. No deaths, serious injuries, or reported illnesses are documented in the source text; the formaldehyde exposure risk is potential rather than realized.
Plain-English summary
Breas Medical, Inc. is recalling the Vivo 45 LS ventilator, a pressure and volume ventilator used to deliver continuous or intermittent mechanical ventilation support to patients. The recall affects approximately 8,298 units distributed nationwide in the United States.
The recall is due to a potential for short-term elevated levels of formaldehyde to be emitted from the device into the patient breathing airpath under specific conditions. Formaldehyde is a respiratory irritant and hazardous substance that could harm patients relying on this device for breathing support.
Patients currently using the Vivo 45 LS and healthcare providers should contact Breas Medical regarding the recalled units. The recall involves all units with lot codes up to 240530 (Model No. 230000, UDI-DI 07321822300004).
The recalled product
- Product
- Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)
- Manufacturer
- Breas Medical, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 8,298
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No 230000
- UDI-DI 07321822300004
- Lot Code: all lots up to 240530.
Distribution
Distributed nationwide across the United States.
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