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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
FastCath		see related information
Date Posted March 01, 2007
Recall Number Z-0535-2007
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
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.
Action The affected customers were notified on 10/5/06 by letter.
Quantity in Commerce 40 Units
Distribution Nationwide.
 
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