Z-1390-2020 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2020
- Initiation Date
- January 16, 2020
- Termination Date
- October 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
Reason for Recall
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
Distribution Pattern
U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
Code Information
Serial Numbers: WAA090630, WAA090724, WAA091212, WAA091456, WAA091468, WAA092596. UDI Code 07340153700031