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U.S. Department of Health and Human Services

Class 3 Device Recall FastCath" Transseptal Guiding Introducer

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 Class 3 Recall
FastCath" Transseptal Guiding Introducer
see related information
Date Posted December 28, 2012
Recall Status1 Terminated on July 12, 2013
Recall Number Z-0617-2013
Recall Event ID 63855
Premarket Notification
510(K) Number
K964518 
Product Classification Introducer, Catheter - Product Code DYB
Product 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.
Code Information Model no. 406586 Batch no. 3619533
Recalling Firm/
Manufacturer
St Jude Medical Inc
177 E County Road B
Saint Paul, Minnesota 55117-1951
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action St Jude Medical hand delivered the" Product Recall" letter dated March 27, 2012, to the affected customers on April 5, 2012, and March 28, 2012. The letter identified the product, the problem and the action needed to be taken by the customer. The returned devices and those not distributed were quarantined at the SJM Minnetonka distribution center until their destruction. Customers were requested to to complete and return the reconciliation form. Further questions please call (651) 756-6526.
Quantity in Commerce 26
Distribution US Distribution only including the states of FL, KY and OK.
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
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DYB and Original Applicant = DAIG CORP.
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