FDA recall Z-2690-2024

Breas Medical, Inc. · Class I · 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)

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

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2024-07-25
Report date
2024-09-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2690-2024