FDA recall Z-1385-2022

Product

HAMILTON-H900 Humidifier, Models: 950001, 950004

Reason for recall

When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.

Distribution

US: WI, FL, CA, NV, PA, TX, PA

Key facts

Status

Completed

Initiation date

2021-01-05

Report date

2022-07-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bonaduz, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1385-2022