Recall Z-1237-2016— Cook Inc.

Name: FDA recall Z-1237-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-27

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2016-01-27, terminated 2017-05-17. It names one FDA 510(k) clearance: K024050. 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.. 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..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-27
Terminated: 2017-05-17
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K024050 — COOK NEPHROSTOMY DILATION BALLOON CATHETER SETCook Urological, Inc.·cleared 2003-02-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.