Recall Z-1238-2016 ยท LJE Catheter, Nephrostomy
Cook Inc.
Ascend AQ Ureteral Dilation Balloon Catheter Set The Ascend AQ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend AQ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation.
| Date | Mar 24, 2016 (initiated Jan 27, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| 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, pleas |
| Quantity | 20 |
| Distribution | Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K024050 | COOK NEPHROSTOMY DILATION BALLOON CATHETER SET Cook Urological, Inc., Feb 27, 2003 |