—#71013

Product

Stryker Ureteral Kit, Model number 220-180-516, 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.

FDA product code: FCS — Light, Catheter, Fiberoptic, Glass, Ureteral
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K982542
Affected lot / code info: Lot numbers 4023, 4105, 4158, 4360, 4524, 4585, 4740, 4862, 4880, 5070, 5211, and 5328

Why it was recalled

Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138

Distribution

Distribution pattern: Product was distributed nationwide and to Australia, Canada, Scandinavia, Italy and Switzerland

Timeline

Recall initiated: 2008-05-09
Posted by FDA: 2008-09-16
Terminated: 2010-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.