Z-1249-2022 Class II Ongoing
FDA device recall Z-1249-2022 was initiated by Getinge Usa Sales Inc on Apr 13, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 11 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 15, 2022
- Initiation Date
- Apr 13, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1249-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026