Cook Inc.: Medical Device Recall in 2016 - (Recall #: Z-1237-2016)

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:

UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.

Product Classification:

Class II

Date Initiated: January 27, 2016

Date Posted: March 30, 2016

Recall Number: Z-1237-2016

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 # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 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