FDAClass IJuly 31, 2013

AlboGraft Knitted with Collagen recall

AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to…

Why was AlboGraft Knitted with Collagen recalled?

Blood blushing/leaking from the surface of the graft after implantation

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number/Expiration Date 56890A 2015-04

Product
AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to…
Recalling firm
LeMaitre Vascular, Inc.
Quantity
2 units
Distribution
Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.
Recall date
July 31, 2013
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls