BEUDAMED
    FDA Enforcement Class II 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 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1238-2016
    Event ID
    73398
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 30, 2016
    Initiation Date
    January 27, 2016
    Classification Date
    March 24, 2016
    Termination Date
    May 17, 2017
    Address
    750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States

    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.

    Code Info

    Catalog # AUBS-6-4 GPN# G32840 Lot# 5083854 Exp: 06/01/2017

    Distribution

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

    Quantity

    20