FDA recall Z-0484-2021

Product

Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.

Reason for recall

Under certain conditions, there is a risk for fire.

Distribution

US Nationwide distribution including in the states of AR, AZ, CA, DE, FL, IL, IN, KY, MN, NC, NM, NV, NY, OH, OK, TX, UT, VA, VT, WI.

Key facts

Status

Terminated

Initiation date

2020-11-12

Report date

2020-12-02

Termination date

2022-11-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0484-2021