FDA Recall Terminated

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.

Recall: Z-1237-2016 · Initiated January 27, 2016

Recall

Recall Number: Z-1237-2016
Event Number: 73398
Firm: Cook Inc.
FEI Number: 1820334
Product Code: LJE
Status: Terminated
Root Cause: Labeling mix-ups
Initiated: January 27, 2016
Posted: March 24, 2016
Terminated: May 17, 2017
Address: 750 N Daniels Way, Bloomington, IN, 47404-9120

Description

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.

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.

Distribution

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

Quantity