BEUDAMED
    FDA Recall Terminated

    American Catheter / Cholangiogram Catheter 9100 Series.

    Recall: Z-2191-2015 · Initiated March 17, 2015

    Recall

    Recall Number
    Z-2191-2015
    Event Number
    71263
    Firm
    American Catheter Corp
    FEI Number
    1000151187
    Product Code
    GBZ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 17, 2015
    Posted
    July 22, 2015
    Terminated
    December 14, 2016
    Address
    13047 S Highway 475, Ocala, FL, 34480-8503

    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.

    Action

    Consignees were contacted by telephone of the affected lot number and sent a Recall Script dated 3/17/2015 giving instructions how to respond to this recall.

    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.