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Class 2 Device Recall QuickCat |
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Date Initiated by Firm |
July 01, 2010 |
Date Posted |
August 09, 2010 |
Recall Status1 |
Terminated 3 on August 20, 2010 |
Recall Number |
Z-2190-2010 |
Recall Event ID |
56115 |
510(K)Number |
K060092 K073519
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Product Classification |
Extraction catheter - Product Code DXE
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Product |
Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels. |
Code Information |
Lot numbers FQT09K07A through FQT10F09A. |
Recalling Firm/ Manufacturer |
Spectranetics Corporation 96 Talamine Ct Colorado Springs CO 80907-5159
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For Additional Information Contact |
719-447-2539
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Manufacturer Reason for Recall |
Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
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FDA Determined Cause 2 |
Process control |
Action |
Consignees were notified by letter on Jul 1, 2010, and told to not use affected lots and to contact Spectranetics to arrange a product exchange. More information is available at 800-231-0978. |
Quantity in Commerce |
5080 units (1778 US, 3302 Non-US) |
Distribution |
Worldwide distribution: USA, Argentina, Austria, Belgium, Brazil, Chile, Czech Republic, Finland, France, French Polynesia, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, and Venezuela. |
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 = DXE and Original Applicant = KENSEY NASH CORP.
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