Date Initiated by Firm | November 23, 2004 |
Date Posted | December 24, 2004 |
Recall Status1 |
Terminated 3 on December 26, 2006 |
Recall Number | Z-0350-05 |
Recall Event ID |
30481 |
PMA Number | P000039 P020024 |
Product Classification |
unknown device name - Product Code GBK
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Product | Amplatzer Delivery Systems (45-degree curve). order no. 9-DEL-6F-45/60. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchang Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN. |
Code Information |
00E01-13, M02K07-44, M03C24-17, M03E27-07, M03F18-09, M03L11-45, M04B09-16, M04E27-19 |
Recalling Firm/ Manufacturer |
AGA Medical Corporation 682 Mendelssohn Ave N Golden Valley MN 55427-4306
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For Additional Information Contact | Jody Raus 763-513-9227 |
Manufacturer Reason for Recall | Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing. |
FDA Determined Cause 2 | Other |
Action | Recall notices were sent via e-mail 11/22/04 to physicians, hospitals and distributors who received affected product. Hard copies of the Recall Notices were sent to all customers (international and domestic) via Federal Express 11/22-24/04. A form that is attached to the Recall Notice asks for customers to fill out quantities of affected product and to return the affected product to AGA Medical. |
Quantity in Commerce | 1329 |
Distribution | Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia. |
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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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