Getinge 46-Series Washer Disinfector # 46-4 recalled over fire hazard

Recall date

January 16, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Maquet Cardiovascular Us Sales, Llc recalls Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Centr…

Recall number

Z-1391-2020

FDA classification

Class III

Brand / firm

Maquet Cardiovascular Us Sales, Llc

Sold / distributed

U.S. Distribution: CA, CO, IA, MN, NY, SC, VA

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 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.