BEUDAMED
    FDA Recall Terminated

    Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments, containers, operating theatre shoes and operating theatre accessories normally used in hospitals and central disinfection facilities. The disinfected items must be further processed through terminal sterilization before use in any surgical procedure.

    Recall: Z-1124-2021 · Initiated December 21, 2020

    Recall

    Recall Number
    Z-1124-2021
    Event Number
    87155
    Firm
    Getinge Group Logistics America, LLC
    FEI Number
    3025504317
    Product Code
    MEC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 21, 2020
    Terminated
    July 20, 2022
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments, containers, operating theatre shoes and operating theatre accessories normally used in hospitals and central disinfection facilities. The disinfected items must be further processed through terminal sterilization before use in any surgical procedure.

    Reason

    The potential that the plastic inlet hose connections may deform or break as a result of material fatigue and/or over tightening of the clamps. A broken hose connection may lead to a hazardous situation of water leakage or water spray. The water leakage or water spray may result in a burn to the user and/or an inconvenience due to a procedural delay if the Washer Disinfector is taken out of service.

    Action

    On 01/12/2021 Getinge initiated a voluntary Medical Device in the U.S for the CM320 Series Washer Disinfector instructing consignees to inspect their device and that a correction kit is currently available and the correction will be completed at no cost to affected customers.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of ND, PA, NC, VA, NE, MD, NY, MN and the countries of Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hong Kong, Norway, Slovakia, Slovenia, South Korea, Sweden, Japan, China, Netherland, Italy, Kuwait and Czech Republic.

    Quantity

    189 units total (Domestic 19 units, Foreign 170 units)