Maquet Cardiovascular Us Sales, Llc: 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 O

Is my product affected?

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.

• UPC 07340153700031

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

What happened

Maquet Cardiovascular US Sales, LLC is recalling Getinge 46-Series Washer Disinfector Model #46-4 units used in medical facilities' Central Sterile Supply Departments. The recall affects four units distributed across California, Colorado, Iowa, Minnesota, New York, South Carolina, and Virginia. These units are missing the water intake components (valve, hose, and clamps) needed for deionized water, which prevented proper installation. The affected serial numbers are WAA090630, WAA090724, WAA091212, WAA091456, WAA091468, and WAA092596.

No serious illnesses or injuries have been reported related to this issue. The recall documentation does not specify a remedy or corrective action that 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: 4 units Lot/code info: Serial Numbers: WAA090630, WAA090724, WAA091212, WAA091456, WAA091468, WAA092596. UDI Code 07340153700031

Source

Official record: FDA (Device enforcement) ↗

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

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