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Terminated

EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation.

FDA Recall Z-1647-2012 · Posted 2012-05-22

Recalling FirmBiosense Webster, Inc.
Recall StatusTerminated
Product CodeDRF
Date Initiated2007-12-15
Date Terminated2012-05-23
Product Quantity1 unit

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.

Firm 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.

Root Cause

Incorrect or no expiration date

Distribution Pattern

Nationwide distribution: CA only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101345WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,Biosense Webster, Inc. · 2010-06-22K090898CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEERBiosense Webster, Inc. · 2009-09-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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