Recall Z-0977-2020 ยท FAD Stent, Ureteral
Cook Inc.
Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
| Date | Jan 4, 2019 |
| Status | Terminated |
| Reason | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. |
| Root cause | Process control |
| Action | On January 4, 2019, the firm distributed Urgent Medical Device Recall letters to customers via courier mail. Customers were informed that affected lots may contain a wire guide that was incorrectly loaded into the wire guide holder. |
| Quantity | 13388 total |
| Distribution | Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961446 | AQ HYDROPHILIC STENT Cook Urological, Inc., May 28, 1996 |