Z-2690-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2024
- Initiation Date
- July 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8298
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)
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.
Distribution Pattern
US Nationwide.
Code Information
Model No 230000; UDI-DI 07321822300004; Lot Code: all lots up to 240530.