BEUDAMED
    FDA Recall Open, Classified

    Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD

    Recall: Z-1249-2022 · Initiated April 13, 2022

    Recall

    Recall Number
    Z-1249-2022
    Event Number
    90146
    Firm
    Getinge Usa Sales Inc
    FEI Number
    3013876692
    Product Code
    MEC
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 13, 2022
    Address
    1 Geoffrey Way, Wayne, NJ, 07470-2035

    Description

    Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD

    Reason

    Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection

    Action

    Getinge issued to U.S. consignees Medical Device Correction Letter dated April 13, 2022 via FedEx delivery. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any Getinge CM320-series Washer Disinfectors with the REF number/serial numbers listed on page 1. You can continue to use Getinge CM320-series Washer Disinfectors until the corrective action is performed; there are no precautionary actions necessary. 2. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 5) to acknowledge that you have received this notification. A Getinge service technician will review the Installation Checklist and verify that each of the steps were performed to ensure continual safe operation of your cart washer(s). This review and verification will be performed. Questions contact your Getinge representative or Technical Support please call (888) 943-8872 (options 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). Technical Support can also be reached via email at [email protected].

    Distribution

    US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.

    Quantity

    11 units