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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Event Detail

Event ID 65553
Product Type Devices
Status Ongoing
Recalling Firm LeMaitre Vascular, Inc.
City Burlington
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-17
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 1 unit Z-1754-2013
AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 2 units Z-1755-2013
Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 7 units Z-1756-2013
AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 3 units Z-1757-2013
AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 1 unit Z-1758-2013
AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 3 units Z-1759-2013
AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 1 unit Z-1760-2013
AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 3 units Z-1761-2013
AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 3 units Z-1762-2013
AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 2 untis Z-1763-2013
AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 2 units Z-1764-2013
AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 2 units Z-1765-2013
AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 2 units Z-1766-2013
AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 1 unit Z-1767-2013
AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 1 unit Z-1768-2013
AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 2 units Z-1769-2013
AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. Lot number/Expiration Date 56890A 2015-04 Class I Blood blushing/leaking from the surface of the graft after implantation 3 units Z-1770-2013
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