BEUDAMED
    FDA Enforcement Class III Terminated

    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.

    Recall: Z-1391-2020 · Reported March 4, 2020

    Enforcement

    Recall Number
    Z-1391-2020
    Event ID
    84885
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Cardiovascular Us Sales, Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2020
    Initiation Date
    January 16, 2020
    Classification Date
    February 27, 2020
    Termination Date
    October 23, 2023
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    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.

    Reason

    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.

    Code Info

    Serial Numbers: WAA090094, WAA090112, WAA090409, WAA090521, WAA090757, WAA090805, WAA091170, WAA091288, WAA091292, WAA091454, WAA091460 WAA091463, WAA091477. UDI Code 07340153700048

    Distribution

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

    Quantity

    7 units