Recall Z-0758-2016 ยท MCW Catheter, Peripheral, Atherectomy
Spectranetics Corp.
2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy device designed for use with the CVX-300" Excimer Laser System. The Turbo-Power Laser Atherectomy Catheter is a sterile, single use, prescription only device used for peripheral atherectomy. Turbo-Power is used exclusively with SPNC s CVX 300" Excimer Laser Syste
| Date | Feb 5, 2016 (initiated Jan 15, 2016) |
| Status | Terminated |
| Reason | The product is labeled with an expiration date that is past its shelf life. |
| Root cause | Error in labeling |
| Action | Spectranectics sent a Medical Device Field Action letter dated January 15, 2016 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and set aside the affected product and contact Customer Service at 1-800-231-0978 to arrange a product exchange. Customers were asked to document the return on the enclosed Field Action Acknowledgement and Receipt Form. Customers with additional questions were instructed to contact their local Spectranetics sales representative. For questions regarding this r |
| Quantity | 8 units |
| Distribution | Nationwide distribution to Florida, North Carolina and Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152181 | Turbo-Power Laser Atherectomy Catheter Spectranetics, Inc., Nov 12, 2015 |