BEUDAMED
    FDA Recall Terminated

    Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050.

    Recall: Z-0966-2011 · Initiated December 13, 2010

    Recall

    Recall Number
    Z-0966-2011
    Event Number
    57708
    Firm
    Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN
    FEI Number
    1825146
    Product Code
    KOD
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 13, 2010
    Posted
    January 25, 2011
    Terminated
    January 31, 2011
    Address
    1100 W Morgan St, Spencer, IN, 47460-9426

    Description

    Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050.

    Reason

    The firm received a complaint that 15 units of the Koyle Diaper Stent were received in packages that had not been sealed. Each stent should be sealed in a poly-Tyvek pouch.

    Action

    The firm sent an URGENT RECALL NOTICE to one consignee on 12/13/2010 (the other consignee returned all their product as a complaint). The letter informed the consignee of the recall and asked the customer to return the recalled product.

    Distribution

    CA, CT

    Quantity

    25 stents