Breas Medical, Inc.: Device Recall
Recall #Z-2690-2024 · 07/25/2024
Class I: Dangerous
Recall Details
- Recall Number
- Z-2690-2024
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Breas Medical, Inc.
- Status
- Ongoing
- Date Initiated
- 07/25/2024
- Location
- North Billerica, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8298
Reason for Recall
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.
Product Description
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)
Distribution Pattern
US Nationwide.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.