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.
- Company
- Spectranetics Corporation
- Recall Initiated
- July 18, 2011
- Posted
- August 4, 2011
- Terminated
- August 12, 2011
- Recall Number
- Z-2952-2011
- Quantity
- 123 units
- Firm Location
- Colorado Springs, CO
Reason for Recall
Packaging integrity may be compromised, thus sterility can not be assured.
Distribution
Foreign Distribution-including the countries of Belgium, Cyprus, Germany, Greece, Italy, Spain, Switzerland, and United Kingdom.
Lot / Code Info
Lot Numbers: CMP09L24C, CTB09G21A, FTB09M11A, FTB10C02A, FTB10F14A, FTB10H17B, FTB11D12A.
Root Cause
Package design/selection
Action Taken
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.