BEUDAMED
    FDA Recall Terminated

    REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.

    Recall: Z-0812-2016 · Initiated January 4, 2016

    Recall

    Recall Number
    Z-0812-2016
    Event Number
    72977
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    KYZ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 4, 2016
    Posted
    February 16, 2016
    Terminated
    June 6, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    Description

    REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.

    Reason

    Report by a customer of an open package seal.

    Action

    BMD sent an Urgent Medical Product Recall letter to each of the customers via FedEx with proof of delivery notice. The leter identified the affected product, problem and actions to be taken. All consignees were instructed to carry out the recall to the user level. The letter included a Recall and Effectiveness Check Form which was to be returned to Bard.

    Distribution

    US Nationwide Distribution - in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, and Puerto Rico

    Quantity

    15,400 units