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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 21, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on March 31, 2005
Recall Number Z-1006-04
Recall Event ID 29172
510(K)Number k000615  
Product Classification Catheter, Electrode Recording, Or Probe, Electrode Recording - Product Code DRF
Product Quickcable Autoclaveable Cable

Electrode Cable
Code Information Lot 005955
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact Mary McDermott
800-839-8720
Manufacturer Reason
for Recall		 Mislabeling.
FDA Determined
Cause 2		 Other
Action Recall was by letter on May 21, 2004 requesting return of affected lot.
Quantity in Commerce 212
Distribution Nationwide, Australia, Korea, Chile, Brazil.
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.
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