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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Product Detail

Product Description Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
Recall Number Z-0617-2013
Classification Class III
Code Info Model no. 406586 Batch no. 3619533
Product Distributed Qty 26
Reason For Recall St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.

Event Detail

Event Id 63855
Product Type Devices
Status Ongoing
Recalling Firm St Jude Medical Inc
City Saint Paul
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution only including the states of FL, KY and OK.