BEUDAMED
    FDA Recall Terminated

    SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device

    Recall: Z-2333-2016 · Initiated June 29, 2016

    Recall

    Recall Number
    Z-2333-2016
    Event Number
    74610
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    KNX
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 29, 2016
    Terminated
    December 5, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device

    Reason

    Labeling problem

    Action

    Bard Medical sent an Urgent Medical Device Product Recall letter dated June 29, 2016. The letter identified the product, the problem, and the action to be taken by the customer. The letter requested that customers examine their inventory and quarantine the product. The letter also requested a sub-recall. The letter included a reply form which is to be returned to Bard. Customers were also instructed if product was further distributed they identify customers and notify them at once. Customers with questions should contact the BMD Recall Coordinator at 1-800-793-8110.

    Distribution

    Nationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.

    Quantity

    530 units