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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 21, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on March 31, 2005
Recall NumberZ-1006-04
Recall Event ID 29172
Product Classification Catheter, Electrode Recording, Or Probe, Electrode Recording - Product Code DRF
ProductQuickcable Autoclaveable Cable Electrode Cable
Code Information Lot 005955
FEI Number 3003113629
Recalling Firm/
Manufacturer		 Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information ContactMary McDermott
800-839-8720
Manufacturer Reason
for Recall		Mislabeling.
FDA Determined
Cause 2		Other
ActionRecall was by letter on May 21, 2004 requesting return of affected lot.
Quantity in Commerce212
DistributionNationwide, Australia, Korea, Chile, Brazil.
Total Product Life CycleTPLC 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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