Spectranetics Corporation, QuickCat Extraction Catheter, REF 60090-01, Sterile R, Working Length 145cm, for embolus and thrombus removal from arterial vessels.
- Company
- Spectranetics Corporation
- Recall Initiated
- July 1, 2010
- Posted
- August 9, 2010
- Terminated
- August 20, 2010
- Recall Number
- Z-2190-2010
- Quantity
- 5080 units (1778 US, 3302 Non-US)
- Firm Location
- Colorado Springs, CO
Reason for Recall
Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
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.
Lot / Code Info
Lot numbers FQT09K07A through FQT10F09A.
Root Cause
Process control
Action Taken
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.
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