Date Initiated by Firm | June 01, 2006 |
Date Posted | October 20, 2006 |
Recall Status1 |
Terminated 3 on April 01, 2007 |
Recall Number | Z-0053-2007 |
Recall Event ID |
35814 |
Product Classification |
Occluder - Product Code MLV
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Product | AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. |
Code Information |
Lot number M06B01-58, serial numbers 190495 - 190512 |
Recalling Firm/ Manufacturer |
AGA Medical Corporation 682 Mendelssohn Ave N Golden Valley MN 55427-4306
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Manufacturer Reason for Recall | AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. The affected product was not distributed within the United States and does not affect U.S. consignees. |
FDA Determined Cause 2 | Other |
Action | Consignees were notified of the recall via fax and mail. Consignees were instructed to cease distribution and use of the devices. Returned devices will be replaced. |
Quantity in Commerce | 18 |
Distribution | Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic. |
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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