BEUDAMED
    FDA Enforcement Class II Terminated

    American Catheter / Cholangiogram Catheter 9100 Series.

    Recall: Z-2191-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2191-2015
    Event ID
    71263
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    American Catheter Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 29, 2015
    Initiation Date
    March 17, 2015
    Classification Date
    July 22, 2015
    Termination Date
    December 14, 2016
    Address
    13047 S Highway 475, N/A, Ocala, FL, 34480-8503, United States

    Description

    American Catheter / Cholangiogram Catheter 9100 Series.

    Reason

    Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.

    Code Info

    Product Number is 9100, Lot # 14101601.

    Distribution

    Distributed in the states of AL, AK, CA, CO, FL, GA, HI, IL, KS, LA, MI, MO, MT, NJ, OH, OK, SC, TN, TX, WA, and WI.

    Quantity

    890 devices.