Z-1237-2016Class II

UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon...

Name: Z-1237-2016 UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon...
Creator: Cook Inc.
Published: 2016-01-27
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2016-01-27 / Terminated / root cause: labeling and UDI

FDA source

Cook Inc. began a recall of UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The... on 2016-01-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1237-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-27
Posted: 2016-03-24
Terminated: 2017-05-17
Recalling firm: Cook Incorporated
Product: 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 code: LJE Catheter, Nephrostomy
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 20
Distribution: Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
Product codes and lots: Catalog # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 Exp: 06/01/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1237-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1237-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24
Z-1238-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24

Product code LJE

K024050UnclassifiedCook Nephrostomy Dilation Balloon Catheter SetCook Urological, Inc. / cleared 2003-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)