BEUDAMED
    FDA Enforcement Class II Completed

    Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

    Recall: Z-1918-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1918-2025
    Event ID
    96849
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2025
    Initiation Date
    May 13, 2025
    Classification Date
    June 6, 2025
    Address
    3651 Birchwood Dr, Waukegan, IL, 60085-8337, United States

    Description

    Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

    Reason

    Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

    Code Info

    UDI-DI (GTIN) 10885380197925 (EA) 50885380197923 (BX) ALL LOTS

    Distribution

    Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.

    Quantity

    6517 cases total