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
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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 |
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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.
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PMA Database | PMAs with Product Code = MGB
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