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U.S. Department of Health and Human Services

Class 2 Device Recall EZ STEER Catheter

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  Class 2 Device Recall EZ STEER Catheter see related information
Date Initiated by Firm December 15, 2007
Date Posted May 22, 2012
Recall Status1 Terminated 3 on May 23, 2012
Recall Number Z-1647-2012
Recall Event ID 48179
510(K)Number K101345  K090898  
Product Classification Catheter, electrode recording, or probe, electrode recording - Product Code DRF
Product EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter

Cardiovascular catheter for use in electrophysiological diagnosis and ablation.
Code Information Lot Number: 13140790A
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact
909-839-8604
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 1 unit
Distribution Nationwide distribution: CA only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRF and Original Applicant = BIOSENSE WEBSTER, INC.
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