BEUDAMED
    FDA Recall Terminated

    WAVES WCM Kidney Cassette Module

    Recall: Z-1013-2022 · Initiated March 21, 2022

    Recall

    Recall Number
    Z-1013-2022
    Event Number
    89841
    Firm
    Waters Medical Systems LLC
    FEI Number
    2123774
    Product Code
    KDN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 21, 2022
    Terminated
    August 16, 2024
    Address
    2112 15th St NW, Rochester, MN, 55901-0716

    Description

    WAVES WCM Kidney Cassette Module

    Reason

    There is a potential for the WCM cassette pump head leaking solution.

    Action

    WMS communicated the recall through a recall letter on 03/15/2022. The letter instructed all customers to return the product to WMS for evaluation. The goal is 100% product location and recovery. In addition, the letter instructed all customers to fill out information on the recall notification and return to WMS. For like product not involved in the recall, a warning letter was issued. For any product not included in the recall but found to be deficient, customers will be instructed to contact WMS for replacement.

    Distribution

    WCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France.

    Quantity

    75 cases (6ct)