BEUDAMED
    FDA Recall Terminated

    Ascend AQ Ureteral Dilation Balloon Catheter Set The Ascend AQ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend AQ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation.

    Recall: Z-1238-2016 · Initiated January 27, 2016

    Recall

    Recall Number
    Z-1238-2016
    Event Number
    73398
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    LJE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    January 27, 2016
    Posted
    March 24, 2016
    Terminated
    May 17, 2017
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Ascend AQ Ureteral Dilation Balloon Catheter Set The Ascend AQ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend AQ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation.

    Reason

    Cook Medical is voluntarily recalling specific lots of the Ultraxx" Nephrostomy Balloon Set and the Ascend AQ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up. Cook Medical has received reports of packages labeled as Ultraxx" Nephrostomy Balloon Set actually containing the Ascend AQ Ureteral Dilation Balloon Catheter Set and vice versa.

    Action

    Cook Medical sent an Urgent Medical Device Recall Notification letter dated January 27, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to quarantine any unused affected product. Immediately collect and return all unused affected products to Cook Medical If you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235. For questions regarding this recall call 800-457-4500.

    Distribution

    Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.

    Quantity

    20