Recall Z-0963-2020 ยท OCY Endoscopic Guidewire, Gastroenterology-Urology
Cook Inc.
Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
| 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
| K082536 | COOK WIRE GUIDES Cook Urological, Inc., Oct 27, 2008 |