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U.S. Department of Health and Human Services

Class 2 Device Recall Ultraxx

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 Class 2 Device Recall Ultraxxsee related information
Date Initiated by FirmJanuary 27, 2016
Date PostedMarch 24, 2016
Recall Status1 Terminated 3 on May 17, 2017
Recall NumberZ-1237-2016
Recall Event ID 73398
510(K)NumberK024050 
Product Classification Catheter, nephrostomy - Product Code LJE
ProductUltraxxTM 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.
Code Information Catalog # UNBS-1 0-15-CS GPN# G30357 Lot# 5082013 Exp: 06/01/2017
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations
812-339-2235
Manufacturer 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.
FDA Determined
Cause 2		Labeling mix-ups
ActionCook 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 Commerce20
DistributionWorldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LJE
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