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U.S. Department of Health and Human Services

Class 2 Device Recall AngioSeal Vascular Closure Device

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  Class 2 Device Recall AngioSeal Vascular Closure Device see related information
Date Initiated by Firm August 22, 2005
Date Posted March 25, 2006
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-0677-06
Recall Event ID 33329
PMA Number P930038 
Product Classification Device, Hemostasis, Vascular - Product Code MGB
Product Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA.
Code Information Lot number 1146548
Recalling Firm/
Manufacturer		 St. Jude Medical / Daig Division
14901 Deveau Pl
Minnetonka MN 55345-2126
For Additional Information Contact Thomas J. Pepin
952-351-1758
Manufacturer Reason
for Recall		 Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire.
FDA Determined
Cause 2		 Other
Action Letters were delivered to the hospitals and/or doctors in possession of the product instructing them to return it.
Quantity in Commerce 4160
Distribution International Only-Belgium, China, Guadalajara, New Zealand and Thailand.
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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