EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophy
FDA device recall Z-1647-2012 · posted 2012-05-22 · Terminated
Recall details
- Recalling firm
- Biosense Webster, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- DRF
- Quantity affected
- 1 unit
- Distribution
- Nationwide distribution: CA only.
- Date initiated
- 2007-12-15
- Date posted
- 2012-05-22
- Date terminated
- 2012-05-23
- Location
- Irwindale, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, (K101345) | Biosense Webster, Inc. | 2010-06-22 |
| CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER (K090898) | Biosense Webster, Inc. | 2009-09-04 |