FDA recall Z-1249-2022

Getinge Usa Sales Inc · Class II · device

Product

Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD

Reason for recall

Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection

Distribution

US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.

Key facts

Status
Ongoing
Initiation date
2022-04-13
Report date
2022-06-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1249-2022