BEUDAMED
    FDA Enforcement Class II Terminated

    WAVES WCM Kidney Cassette Module

    Recall: Z-1013-2022 · Reported May 4, 2022

    Enforcement

    Recall Number
    Z-1013-2022
    Event ID
    89841
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Waters Medical Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2022
    Initiation Date
    March 21, 2022
    Classification Date
    April 27, 2022
    Termination Date
    August 16, 2024
    Address
    2112 15th St NW, Rochester, MN, 55901-0716, United States

    Description

    WAVES WCM Kidney Cassette Module

    Reason

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

    Code Info

    WCM Kidney Cassette: 1) Lot 123, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; WMS Case (6ct) PN: 3930005.014; EXP 2022-07-01; UDI (Case): *B154W39300050146/$$32207011236* 2) Lot 124, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; WMS Case (6ct) PN: 3930005.014; EXP 2023-01-05; UDI (Case): *B154W39300050146/$$32301051246* 3) Lot 126, packaged in cases; WMS Individual PN: 3930005.011; WMS Cassette Kit PN: 3930005.012; WMS Case (6ct) PN: 3930005.014; EXP 2023-05-17; UDI (Case): *B154W39300050146/$$3230517126F*

    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)