BEUDAMED
    FDA Recall Terminated

    Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0

    Recall: Z-0555-03 · Initiated January 22, 2003

    Recall

    Recall Number
    Z-0555-03
    Event Number
    25427
    Firm
    Cook Urological, Inc.
    FEI Number
    1825146
    Product Code
    EZN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 22, 2003
    Posted
    February 13, 2003
    Terminated
    March 26, 2003
    Address
    1100 West Morgan, Spencer, IN, 47460

    Description

    Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0

    Reason

    Product is labeled sterile, but was not sterilized.

    Action

    Customers were notified by phone call and recall letter beginning on 1/22/03.

    Distribution

    Alaska, Hawaii, Minnesota, Ohio, Tennessee and Ireland.

    Quantity

    9