Recall Z-1647-2012 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Biosense Webster, Inc.
EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation.
| Date | May 22, 2012 (initiated Dec 15, 2007) |
| Status | Terminated |
| Reason | The recall was initiated because the catheter unit was shipped with a label expiration date of 9/30/2010, which is 11 months beyond the correct expiration date of 10/31/2009. |
| Root cause | Incorrect or no expiration date |
| Action | The firm, Biosense Webster, sent a "Medical Device-Voluntary Field Removal" letter dated December 17, 2007 to its customer. The letter identified the product, problem and an action to be taken. The customer was instructed to complete and return the Product Voluntary Field Removal Certification Form via fax to Quality Compliance at (909) 839-7207or mail using the enclosed self-addressed stamped envelope. If you have additional questions, please follow up with your local Biosense Webster representative.or contact Customer Service at (909) 839-8500. |
| Quantity | 1 unit |
| Distribution | Nationwide distribution: CA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090898 | CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER Biosense Webster, Inc., Sep 4, 2009 |
| K101345 | WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, Biosense Webster, Inc., Jun 22, 2010 |