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.
Reported: July 31, 2013 Initiated: June 17, 2013 #Z-1761-2013
Product Description
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.
Reason for Recall
Blood blushing/leaking from the surface of the graft after implantation
Details
- Recalling Firm
- LeMaitre Vascular, Inc.
- Units Affected
- 3 units
- Distribution
- Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.
- Location
- Burlington, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by LeMaitre Vascular, Inc.. Units affected: 3 units.
Why was this product recalled? ▼
Blood blushing/leaking from the surface of the graft after implantation
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 31, 2013. Severity: Critical. Recall number: Z-1761-2013.
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