| Class 2 Device Recall Laser Guide Catheter | |
Date Initiated by Firm | July 18, 2011 |
Date Posted | August 04, 2011 |
Recall Status1 |
Terminated 3 on August 12, 2011 |
Recall Number | Z-2952-2011 |
Recall Event ID |
59382 |
510(K)Number | K071226 |
Product Classification |
Catheter, percutaneous - Product Code DQY
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Product | Spectranetics Turbo-Booster Laser Guide Catheter, 8 Fr, REF 518-063, 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: CMP09L24C, CTB09G21A, FTB09M11A, FTB10C02A, FTB10F14A, FTB10H17B, FTB11D12A. |
Recalling Firm/ Manufacturer |
Spectranetics Corporation 96 Talamine Ct Colorado Springs CO 80907-5159
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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 | 123 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 |
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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 = DQY
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