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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm September 20, 2005
Date Posted November 03, 2005
Recall Status1 Terminated 3 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/
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 2
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 and Original Applicant = DAIG CORP.