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 Recall Z-1866-2008 · Posted 2008-09-16
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Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeFCS
Date Initiated2008-05-09
Date Terminated2010-12-21
Product Quantity4500
Reason for Recall
Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery
Firm 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.
Root Cause
Other
Distribution Pattern
Product was distributed nationwide and to Australia, Canada, Scandinavia, Italy and Switzerland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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