Reported Sep 11, 2024 · Ongoing
Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for…
Breas Medical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Breas Medical, Inc. · 16 Esquire Rd · North Billerica, MA · 01862-2527
Is this the product you have?
- 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 (230016230216)
- Lot codes and dates
Model No 230000UDI-DI 07321822300004
- Lot Codeall lots up to 240530
- Amount recalled
- 8298
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.
Using this product could cause serious injury, illness or death — stop using it now.
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