2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a l
FDA device recall Z-0758-2016 · posted 2016-02-05 · Terminated
Recall details
- Recalling firm
- Spectranetics Corp.
- Reason for recall
- The product is labeled with an expiration date that is past its shelf life.
- Action taken
- 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 recall call 719-447-2318.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MCW
- Quantity affected
- 8 units
- Distribution
- Nationwide distribution to Florida, North Carolina and Pennsylvania.
- Date initiated
- 2016-01-15
- Date posted
- 2016-02-05
- Date terminated
- 2017-03-02
- Location
- Colorado Springs, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Turbo-Power Laser Atherectomy Catheter (K152181) | Spectranetics, Inc. | 2015-11-12 |