Telesheath 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.
Hazard
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.
What You Should Do
Remedy
100% 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.
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Products
Telesheath 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
- Brand
- St. Jude Medical/Daig Division
- UPC
- 1063073 - Exp. Date: 03/2007, 1075105, - Exp. Date: 05/2007 1077015 - Exp. Date: 06/2007, 1079062 - Exp Date: 06/2007
Units Affected
292 kits