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U.S. Department of Health and Human Services

Class 2 Device Recall Ureteral Universal Kit

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  Class 2 Device Recall Ureteral Universal Kit see related information
Date Initiated by Firm May 09, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on December 21, 2010
Recall Number Z-1867-2008
Recall Event ID 48218
Product Classification Ureteral fiberoptic light catheter - Product Code FCS
Product 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.
Code Information Lot numbers 4025, 4169, 4362, 4647, 4711, 5196, and 5461
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138
For Additional Information Contact
408-754-2124
Manufacturer Reason
for Recall		 Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery
FDA Determined
Cause 2		 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 in Commerce 1195 units
Distribution Product was distributed nationwide and to Australia, Canada, Scandinavia, Italy and Switzerland
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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