U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Catheter, nephrostomy - Product Code LJE
원인
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.
조치
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.
Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
제품 설명
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.