Device product
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.
Z-1238-2016
Product summary
- Firm
- Cook Inc.
- Event
- Event 73398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20
- Official record key
device-enforcement:Z-1238-2016
Official wording
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.
Code information: Catalog # AUBS-6-4 GPN# G32840 Lot# 5083854 Exp: 06/01/2017
Distribution pattern: Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally to CHINA.
Derived failure modes
-
Labeling or packaging
labeling mix-up