BEUDAMED
    FDA Enforcement Class III 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 · Reported February 24, 2016

    Enforcement

    Recall Number
    Z-0812-2016
    Event ID
    72977
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 24, 2016
    Initiation Date
    January 4, 2016
    Classification Date
    February 16, 2016
    Termination Date
    June 6, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States

    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.

    Code Info

    Lot Number NGZE1190

    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