FDAFDA · Food and drugs·Recall number Z-2690-2024
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)
Published September 11, 2024 · Recall initiated: July 25, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Breas Medical, Inc.
- Distributor
- US Nationwide.
- Lot
- Model No 230000; UDI-DI 07321822300004; Lot Code: all lots up to 240530.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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