BEUDAMED
    FDA Recall Terminated

    Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.

    Recall: Z-1859-2021 · Initiated April 20, 2021

    Recall

    Recall Number
    Z-1859-2021
    Event Number
    87894
    Firm
    Medivators, Inc.
    FEI Number
    2150060
    Product Code
    FKQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 20, 2021
    Terminated
    July 11, 2024
    Address
    14605 28th Ave N, Plymouth, MN, 55447-4822

    Description

    Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.

    Reason

    The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.

    Action

    On 4/20/21 the firm initiated notification to its consignee via phone call, followed by a letter sent on 4/27/21 with the following instructions: 1. Quarantine and discontinue use of product from lot 489224, including dialysate produced with this lot of concentrate. 2. Contact Medivators Customer Service at 1-800-444-4729 or [email protected] to receive a return material authorization to return any unused product and receive replacement product. 3. Please return the enclosed Acknowledgement form via email to Happy-Sarah Kim at [email protected] 4. If this product was further distributed, notify your customer of the recall.

    Distribution

    US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.

    Quantity

    1,381 CASES