EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation.
- Company
- Biosense Webster, Inc.
- Recall Initiated
- December 15, 2007
- Posted
- May 22, 2012
- Terminated
- May 23, 2012
- Recall Number
- Z-1647-2012
- Quantity
- 1 unit
- Firm Location
- Irwindale, CA
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.
Distribution
Nationwide distribution: CA only.
Lot / Code Info
Lot Number: 13140790A
Root Cause
Incorrect or no expiration date
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.