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U.S. Department of Health and Human Services

Class 3 Device Recall AngioSeal

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  Class 3 Device Recall AngioSeal see related information
Date Initiated by Firm June 07, 2006
Date Posted November 07, 2006
Recall Status1 Terminated 3 on November 13, 2006
Recall Number Z-0157-2007
Recall Event ID 35819
PMA Number P930038S040 
Product Classification Vascular Closure Device - Product Code MGB
Product The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size.
Code Information Lot 1204437
Recalling Firm/
Manufacturer		 St. Jude Medical / Daig Division
14901 Deveau Pl
Minnetonka MN 55345-2126
Manufacturer Reason
for Recall		 The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire.
FDA Determined
Cause 2		 Other
Action All consignees were notified by letter on June 7, 2006. All product is to be retreived by recalling firm''s sales force for return to St. Jude Medical, in Minnetonka, MN.
Quantity in Commerce 4,770 Units
Distribution Nationwide.
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.
PMA Database PMAs with Product Code = MGB and Original Applicant = TERUMO MEDICAL CORPORATION
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