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Class 2 Device Recall Ureteral Kit |
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Date Initiated by Firm |
May 09, 2008 |
Date Posted |
September 16, 2008 |
Recall Status1 |
Terminated 3 on December 21, 2010 |
Recall Number |
Z-1866-2008 |
Recall Event ID |
48218 |
510(K)Number |
K982542
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Product Classification |
Ureteral fiberoptic light catheter - Product Code FCS
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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. |
Code Information |
Lot numbers 4023, 4105, 4158, 4360, 4524, 4585, 4740, 4862, 4880, 5070, 5211, and 5328 |
Recalling Firm/ Manufacturer |
Stryker Endoscopy 5900 Optical Ct San Jose CA 95138
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For Additional Information Contact |
408-754-2124
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Manufacturer Reason for Recall |
Kit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery
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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 |
4500 |
Distribution |
Product was distributed nationwide and to Australia, Canada, Scandinavia, Italy and Switzerland |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = FCS and Original Applicant = Stryker Endoscopy
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