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U.S. Department of Health and Human Services

Class 2 Device Recall PREFACE

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 Class 2 Recall
PREFACE
see related information
Date Posted February 28, 2007
Recall Status1 Terminated on June 25, 2009
Recall Number Z-0537-2007
Recall Event ID 36988
Premarket Notification
510(K) Number
K001139 
Product Classification Introducer, Catheter - Product Code DYB
Product Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803MS
Code Information Lot numbers: 13070991, 13073870, 13073873, 13080117, 13082797 , 13090941, 13099292, 13103566, 13109369, L0103032, L0103066, L0103069, L0103295, L0105007, L0106017, L0106161, L0106271, L0203066, L0206045, L0206152, L0206235, L0206249, L0304237, L0306029, L0306084, L0306161, L0306209, L0404116, L0502384, L0502568, L0504042, L0602226, L0604089, L0704070, L0804173, L0902370, L0902618, L0904056, L0904071, L0904089, L0904134, L0904150, L1002219, L1004025, L1004057, L1004259, L1102088, L1102219, L1205135 & L1205189
Recalling Firm/
Manufacturer
Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale, California 91706-2006
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Rick Fletcher
909-839-8979
Manufacturer Reason
for Recall
Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
Action Initially a Medical Device Correction Advisory letter was mailed on November 20, 2006 to all domestic and international consignees recommending to customers that the Preface Sheath was not to be used with the NaviStar ThermoCool Catheter or any 8 French or larger catheter. On December 9, 2006, a Recall Customer letter and Certification form were sent out to all customers and Johnson & Johnson affiliates who had purchased the product in the past three years. For customers in the US, two letters and forms were sent out -one addressed to the EP/Cardiology Lab and the second to the Risk Management Office. For the US, customers will return product directly to Biosense Webster afler receiving a return authorization number. Returned product will be segregated and labeled as quarantined product. Returned product will be used as necessary for the root cause investigation. Any product not used at the conclusion of the investigation will be destroyed. For international customers, product will be returned to the Biosense Webster warehouse in Roden, Netherlands or to the Biosense Webster US warehouse (depending on order placement) if export issues don''t present a problem. If product cannot be easily returned to Biosense Webster, the customers will be instructed to destroy the product and provide notification that the destruction was performed.
Quantity in Commerce 4565
Distribution Worldwide distribution, including USA, Australia, Brazil, Canada, China, Colombia, Hong Kong, Indonesia, Israel, India, Japan, Korea, the Netherlands, New Zealand, Pakistan, Singapore, Thailand, and Taiwan.
Total Product Life Cycle TPLC Device Report

 
1 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 = DYB and Original Applicant = BIOSENSE WEBSTER, INC.
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