Cook Inc.: Medical Device Recall in 2016 - (Recall #: Z-1238-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: January 27, 2016

Date Posted: March 30, 2016

Recall Number: Z-1238-2016

Event ID: 73398

Reason for Recall:

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.

Status: Terminated

Product Quantity: 20

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated