BEUDAMED
    FDA Recall Terminated

    SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device

    Recall: Z-0967-2017 · Initiated July 11, 2016

    Recall

    Recall Number
    Z-0967-2017
    Event Number
    75952
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    KNX
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 11, 2016
    Terminated
    October 5, 2021
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device

    Reason

    The product contained a latex catheter instead of a silicone catheter.

    Action

    Bard Medical sent an Urgent : Medical Device Product Recall Letter dated July 11, 2016, to all affected customers. The letter requested that they check inventory and quarantine product, and if the product had been further distributed, they need to conduct a sub-recall. The letter included a reply form to be returned. For further questions, please call (770) 784-6220.

    Distribution

    US Distribution to the states of : CA, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, NE, NV, NJ, NM, NY, OR, SC, TN, TX, UT, VA, WA

    Quantity

    2690 units