CLASS II Device recall · Reported 30 Mar 2016 · FDA Enforcement Report

UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy recalled

Cook is recalling UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a, distributed in Georgia, Idaho, Louisiana, Oregon, South Carolina, Texas. The recall was initiated on 27 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 Exp: 06/01/2017

Quantity recalled20

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1237-2016
FDA event ID: 73398
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 27 Jan 2016
FDA classified: 24 Mar 2016
Reported: 30 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

27 Jan 2016	Recall initiated by company
24 Mar 2016	Classified by FDA	+57 days
30 Mar 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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

Georgia Idaho Louisiana Oregon South Carolina Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 Exp: 06/01/2017

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 73398

This product is part of a recall event; the main page for the event is Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set recalled by Cook.

Reported	Class	Recall	Company	Reason	Where
30 Mar 2016	CLASS II	Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set recalled by Cook	Cook	Packaging Defects	6 states

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