Recall Z-1870-2017 ยท FCS Light, Catheter, Fiberoptic, Glass, Ureteral
Cook Inc.
Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
| Date | Apr 19, 2017 (initiated Mar 7, 2017) |
| Status | Terminated |
| Reason | Product may overheat, melt, and burn patient. |
| Root cause | Device Design |
| Action | On 3/7/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. 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. Action To Be Taken: 1. Examine inventory immediately to determine if you have affected products and quarantine affected products. 2. Return the affected products to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. 3. Even if you do not have affected produ |
| Quantity | 19756 |
| Distribution | The devices have been distributed within the United States and the following countries: Bahamas, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Ireland, Israel, Italy, Jerse |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923436 | ILLUMINATED URETERAL CATHETER Cook Urological, Inc., Mar 5, 1993 |