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 pelvic areas to help the surgeon identify the ureter.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Stryker Endoscopy
- Recall Initiated
- May 9, 2008
- Posted
- September 16, 2008
- Terminated
- December 21, 2010
- Recall Number
- Z-1867-2008
- Quantity
- 1195 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery
Distribution
Product was distributed nationwide and to Australia, Canada, Scandinavia, Italy and Switzerland
Lot / Code Info
Lot numbers 4025, 4169, 4362, 4647, 4711, 5196, and 5461
Root Cause
Other
Action Taken
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.
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