Recall Z-1867-2008 ยท FCS Light, Catheter, Fiberoptic, Glass, Ureteral
Stryker Endoscopy
Stryker Ureteral Universal Kit, Model number 220-180-517, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided sterile for single use disposable application. The device is intended to be used to transilluminate the ureter during laparoscopic and open surgical procedures of the lower abdomen or pelv
| Date | Sep 16, 2008 (initiated May 9, 2008) |
| Status | Terminated |
| Reason | Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery |
| Root cause | Other |
| Action | Sales representatives were notified via telephone, and recall product advisory notices will be sent to all consignees on 05/09/2009. Contact a Regulatory Affairs representative at 408-754-2161 or 408-754-2000 should you have any questions. |
| Quantity | 1195 units |
| Distribution | Product was distributed nationwide and to Australia, Canada, Scandinavia, Italy and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.