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Terminated

AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-12F-45/80. 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 Exchange 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.

FDA Recall Z-0357-05 · Posted 2004-12-24

Recalling FirmAGA Medical Corporation
Recall StatusTerminated
Product CodeGBK
Date Initiated2004-11-23
Date Terminated2006-12-26
Product Quantity8452

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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