Class 2 Device Recall PREFACE
|Date Initiated by Firm
||November 17, 2006
|Date Posting Updated
||February 28, 2007
||Terminated 3 on June 25, 2009
|Recall Event ID
||intravascular guiding sheath - Product Code DYB
||Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803M
||Lot numbers:, 13070988,, 13070989,, 13070990,, 13076034,, 13076424,, 13078567,, 13080115,, 13080116,, 13082796,, 13085573,, 13085574,, 13088352,, 13088353,, 13091447,, 13093420,, 13093421,, 13096355,, 13099291,, 13109368,, L0104097,, L0104215,, L0104266,, L0105104,, L0105214,, L0106131,, L0106132,, L0106208,, L0106234,, L0106270,, L0106285,, L0204006
L0204061,, L0204111,, L0204167,, L0204238,, L0205091
L0205143,, L0205192,, L0206043,, L0206068,, L0206124,, L0206125,, L0206151,, L0206191,, L0206192,, L0206218,, L0206219,, L0206234,, L0304028,, L0304057,, L0304183,, L0304236,, L0304299,, L0306043,, L0306063,, L0306083,, L0306110,, L0306158,, L0306159,, L0306208,, L0306283,, L0404094,, L0404117,, L0404178,, L0503121,, L0503213,, L0504077
L0505268,, L0603074,, L0603133,, L0603177,, L0603236,, L0604058
L0604144,, L0604188,, L0604208
L0604241,, L0605013,, L0605214,, L0702464
L0704299,, L0802069,, L0803131,, L0804040, , L0804100,, L0804171
L0805226,, L0902225,, L0902617,, L0903105,, L0903142,, L0903195,, L0904055,, L0904070
L1002270,, L1003019,, L1003256,, L1004024
L1005200,, L1005274,, L1103144
L1205168,, L1205169,, L204167 &, LO604088
| Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
|For Additional Information Contact
|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.
||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
||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 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)s with Product Code = DYB and Original Applicant = BIOSENSE WEBSTER, INC.