Z-1249-2022 Class II Ongoing

Recalled by Getinge Usa Sales Inc — Wayne, NJ

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
11 units

Product Description

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 Pattern

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

Code Information

UDI-DI: 07340153700192 Serial Numbers: W50026718 W50029991 WAA081312 W50039234 WAA062340 WAA062341 WAA070619 WAA085063 WAA089556 WAA093936 WAA094247