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U.S. Department of Health and Human Services

Class 2 Device Recall Telesheath Catheter TwoPiece Introducer Kit with Hemostasis Valve

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 Class 2 Device Recall Telesheath Catheter TwoPiece Introducer Kit with Hemostasis Valvesee related information
Date Initiated by FirmAugust 04, 2004
Date PostedSeptember 01, 2004
Recall Status1 Terminated 3 on November 21, 2005
Recall NumberZ-1425-04
Recall Event ID 29848
510(K)NumberK964518 K973840 K982187 
Product Classification Introducer, Catheter - Product Code DYB
ProductTelesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. The product is packaged in an open, semi-rigid plastic tray, which is then placed in a sterile barrier pouch consisting of Tyvek on one side and a clear plastic film on the other. This pouch is then heat sealed prior to sterilization.
Code Information 1063073 - Exp. Date: 03/2007, 1075105, - Exp. Date: 05/2007 1077015 - Exp. Date: 06/2007, 1079062 - Exp Date: 06/2007
Recalling Firm/
Manufacturer		 St. Jude Medical/Daig Division
14901 Deveau Pl
Minnetonka MN 55345-2126
For Additional Information ContactThomas J. Pepin
952-351-1758
Manufacturer Reason
for Recall		St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis.
FDA Determined
Cause 2		Other
Action100% of customers were notified by a personal visit by a St. Jude Medical representative, starting 8/4/2004. Letters were given by the representative to the consignee concerning the recall.
Quantity in Commerce292 kits
DistributionUS, Canada, Belgium, Hong Kong, and Japan.
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.
510(K) Database510(K)s with Product Code = DYB
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