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U.S. Department of Health and Human Services

Class 2 Device Recall FastCath

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 Class 2 Recall
FastCath
see related information
Date Posted March 01, 2007
Recall Status1 Terminated on May 25, 2007
Recall Number Z-0535-2007
Recall Event ID 36605
Premarket Notification
510(K) Number
K964518 
Product Classification Introducer, Catheter - Product Code DYB
Product FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.
Code Information Lot number 1239904
Recalling Firm/
Manufacturer
St. Jude Medical / Daig Division
14901 Deveau Pl
Minnetonka, Minnesota 55345-2126
Manufacturer Reason
for Recall
Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The affected customers were notified on 10/5/06 by letter.
Quantity in Commerce 40 Units
Distribution Nationwide.
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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