BEUDAMED
    FDA Recall Terminated

    EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F

    Recall: Z-2209-2020 · Initiated June 14, 2019

    Recall

    Recall Number
    Z-2209-2020
    Event Number
    85510
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    MSD
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    June 14, 2019
    Terminated
    September 18, 2024
    Address
    1625 W 3rd St, Bldg 1, Tempe, AZ, 85281-2438

    Description

    EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F

    Reason

    Incorrect Peel-Apart Introducer Sheath in Kit.

    Action

    On 06/14/2019, an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter was sent to each of the US consignees via FedEx with proof of delivery notification.

    Distribution

    67 US Consignees. US - AL, AR, AZ, CA, FL, GA, IA, ID, IL, KY, LA, MD, MN, MT, NC, NY, OR, PA, TN, TX, VA, WA, WI and WV.

    Quantity

    400