FDA recall Z-0943-2022

Product

Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384

Reason for recall

Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity

Distribution

US Nationwide

Key facts

Status

Terminated

Initiation date

2022-03-21

Report date

2022-04-20

Termination date

2024-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0943-2022