Maquet Cardiovascular Us Sales, Llc: 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 O

Is my product affected?

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.

• UPC 07340153700048

Check against the official notice below — it lists the full affected range.

What happened

Maquet Cardiovascular US Sales, LLC is recalling seven Getinge 46-Series Washer Disinfector Model #46-4 units due to missing water intake components for deionized water. The affected units lack the necessary valve, hose, and clamps for this option, making proper installation impossible. The devices were distributed in California, Colorado, Iowa, Minnesota, New York, South Carolina, and Virginia. No injuries or serious illnesses have been reported from this issue.

The affected serial numbers are WAA090094, WAA090112, WAA090409, WAA090521, WAA090757, WAA090805, WAA091170, WAA091288, WAA091292, WAA091454, WAA091460, WAA091463, and WAA091477. The recall record does not specify a remedy or what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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: U.S. Distribution: CA, CO, IA, MN, NY, SC, VA Quantity: 7 units Lot/code info: Serial Numbers: WAA090094, WAA090112, WAA090409, WAA090521, WAA090757, WAA090805, WAA091170, WAA091288, WAA091292, WAA091454, WAA091460 WAA091463, WAA091477. UDI Code 07340153700048

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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