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U.S. Department of Health and Human Services

Class 2 Device Recall Laser Guide Catheter

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  Class 2 Device Recall Laser Guide Catheter see related information
Date Initiated by Firm July 18, 2011
Date Posted August 04, 2011
Recall Status1 Terminated 3 on August 12, 2011
Recall Number Z-2951-2011
Recall Event ID 59382
510(K)Number K071226  
Product Classification Catheter, percutaneous - Product Code DQY
Product Spectranetics Turbo-Booster Laser Guide Catheter, 7 Fr, REF 518-043, Sterile EO, Spectranetics Corporation, 96 Talamine Court, Colorado Springs, CO 80907.

Designed for directing and supporting Spectranetics laser catheters for use in the treatment of infrainguinal stenoses and occlusions.
Code Information Lot Numbers: CTB09K14A, FTB09L25C, FTB09M01A, FTB09M02A, FTB10B10B, FTB10F28A, FTB10G12A.
Recalling Firm/
Manufacturer		 Spectranetics Corporation
96 Talamine Ct
Colorado Springs CO 80907-5159
For Additional Information Contact Donald C. Fletcher
719-447-2000
Manufacturer Reason
for Recall		 Packaging integrity may be compromised, thus sterility can not be assured.
FDA Determined
Cause 2		 Package design/selection
Action Spectranetics sent an "PRODUCT RECALL NOTICE: EU SHIPMENTS OF TURBO-BOOSTER LASER GUIDE CATHETERS" letter dated July 15, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and set aside affected product. Customers are to contact their sales representative for information on how to return the affected product and receive replacement product. Further information is available at +011.49.719.447.2539.
Quantity in Commerce 57 units
Distribution Foreign Distribution-including the countries of Belgium, Cyprus, Germany, Greece, Italy, Spain, Switzerland, and United Kingdom.
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.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = SPECTRANETICS CORP.
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