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Recall Observatory FDA recall evidence

Device 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)

Z-2690-2024

July 25, 2024

Class I

Product summary

Firm
Breas Medical, Inc.
Event
Event 95042
Status
Ongoing
Classification
Class I
Quantity
8298
Official record key
device-enforcement:Z-2690-2024

Official wording

Reason: 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.

Code information: Model No 230000; UDI-DI 07321822300004; Lot Code: all lots up to 240530.

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.