Recall Z-2951-2011 ยท DQY Catheter, Percutaneous
Spectranetics Corporation
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.
| Date | Aug 4, 2011 (initiated Jul 18, 2011) |
| Status | Terminated |
| Reason | Packaging integrity may be compromised, thus sterility can not be assured. |
| Root cause | 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 | 57 units |
| Distribution | Foreign Distribution-including the countries of Belgium, Cyprus, Germany, Greece, Italy, Spain, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071226 | 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 Spectranetics Corp., Jun 29, 2007 |