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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0350-05 - 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, deliver...
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2
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12/24/2004
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AGA Medical Corporation
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Z-0366-05 - AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-8F-180/80. Product is labeled as Sterile EO.
The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZE...
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2
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12/24/2004
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AGA Medical Corporation
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Z-0352-05 - AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable...
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2
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12/24/2004
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AGA Medical Corporation
|
Z-0353-05 - AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/60. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable,...
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2
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12/24/2004
|
AGA Medical Corporation
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Z-0354-05 - AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable...
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2
|
12/24/2004
|
AGA Medical Corporation
|
Z-0355-05 - AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-9F-45/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable...
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2
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12/24/2004
|
AGA Medical Corporation
|
Z-0356-05 - AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-10F-45/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cabl...
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2
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12/24/2004
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AGA Medical Corporation
|
Z-0357-05 - 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 cabl...
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2
|
12/24/2004
|
AGA Medical Corporation
|
Z-0358-05 - AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-5F-180/60. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cab...
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2
|
12/24/2004
|
AGA Medical Corporation
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Z-0359-05 - AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-6F-180/80. Product is labeled as Sterile EO.
Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cab...
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2
|
12/24/2004
|
AGA Medical Corporation
|