BEUDAMED
    FDA Recall Terminated

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    Recall: Z-1739-2022 · Initiated July 26, 2022

    Recall

    Recall Number
    Z-1739-2022
    Event Number
    90739
    Firm
    Isopure Corp
    FEI Number
    3013942511
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 26, 2022
    Posted
    September 13, 2022
    Terminated
    May 31, 2024
    Address
    11851 Plantside Dr, Louisville, KY, 40299-6328

    Description

    Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262

    Reason

    Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching

    Action

    Isopure initiated contact via telephone on 7/26/22 followed by Emails to consignees. .Letter states reason for recall, health risk and action to take: 1. Refer to Distribution List of ACDS units installed. 2. Perform an inspection of the ACDS device, associated wiring, cabling and cord. Provide a photograph if damage is found during inspection. 3. Video links are included in the inspection packet of the Isopure ACDS Instructions for Electrical Review and Preventive Maintenance of the ACDS and proper use of a torque screwdriver as a guide to inspecting electrical connections WI-50602. Please follow these guidance documents. Adhere to all safety information provided. 4. Fill out the Acknowledgement and Inspection Form upon completion of the inspection. Return the Acknowledgment form back to Isopure to [email protected] by September 30, 2022. 5. Always replace any depleted or blown fuses with the correct type and correct rating. 6. Follow the recommended preventive maintenance schedule for the device (refer to LA704262 ACDS Acidified Concentrate Distribution and Storage System User Manual). 7. Contact Isopure Customer/Technical Support at 502-967-7873 with any questions or concerns. Refer to: How -To-Video- Instructions ACDS Preventive Maintenance Instructions https://vimeo.com/732224767

    Distribution

    US Nationwide distribution.

    Quantity

    595 units