FDAJanuary 16, 2020device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

maquet cardiovascular us salesmaquetmaquet cardiovascular

UPCs

07340153700048

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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