Class 3 Device Recall

• Date Initiated by Firm: September 20, 2005
• Date Posted: November 03, 2005
• Recall Status: Terminated on July 22, 2006
• Recall Number: Z-0125-06
• Recall Event ID: 33702
• 510(K)Number: K884494
• Product Classification: Introducer, Catheter - Product Code DYB
• Product: Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude medical, DAIG Division, Inc., Minnetonka, MN 55345-2126 USA
• Code Information: Lot 1164732
• Recalling Firm/ Manufacturer: St. Jude Medical / Daig Division; 14901 Deveau Pl; Minnetonka MN 55345-2126
• Manufacturer Reason for Recall: A lot of product contains a 6F Obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. The Obturator is correctly sized (6F) per the labeling on both the sterile bag and shelf carton.
• FDA Determined Cause: Other
• Action: A letter dated 09/20/05 was sent to all customers explaining the issue and instructed customers that a St. Jude Medical Representative will facilitate in the product removel process. Full credit will be issued.
• Quantity in Commerce: 2000
• Distribution: CA, FL, KY, IL, MN, NY, OH, TN, VA & WI
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DYB