BEUDAMED
    FDA Recall Terminated

    Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.

    Recall: Z-1584-05 · Initiated August 1, 2005

    Recall

    Recall Number
    Z-1584-05
    Event Number
    32912
    Firm
    Cook Urological, Inc.
    FEI Number
    1825146
    Product Code
    KOE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 1, 2005
    Posted
    September 24, 2005
    Terminated
    October 26, 2005
    Address
    1100 W Morgan St, Spencer, IN, 47460-9426

    Description

    Cook brand Fascial Dilator; 10FR/37cm, sterile, Rx Only, Cook Ireland Ltd., Limerick, Ireland; REF G14191; Catalog No. 073710.

    Reason

    Mislabeled as to size.

    Action

    The firm advised the hospital customers of the recall by phone on 7/6/05 and asked that the products be returned. One customer was sent a UPS call tag for return of the product and the other customer was requested to refuse receipt of their shipment in transit.

    Distribution

    California and Florida.

    Quantity

    3