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Maquet Cardiovascular Us Sales, Llc recalls Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Centra
Recalled March 4, 2020 · FDA recall Z-1390-2020 · Maquet Cardiovascular Us Sales
Hazard
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. · FDA Class III
Units
4 units
Sold at
U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
Description
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.
Product
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.
Manufacturer(s)
Maquet Cardiovascular Us Sales, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →