Z-1248-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 15, 2022
- Initiation Date
- April 13, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
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 Pattern
US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.
Code Information
UDI-DI: 07340153700185 Serial Numbers: W50034570 WAA070170 WAA070618 WAA081312