Z-1427-2010

InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France...

Name: Z-1427-2010 InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France...
Creator: Intervascular S.A.S.
Published: 2009-12-09
License: https://open.fda.gov/license/

Intervascular SAS / initiated 2009-12-09 / Terminated / root cause: labeling and UDI

FDA source

Intervascular S.A.S. began a recall of InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement... on 2009-12-09. The reason FDA records is "Packaging was mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1427-2010
Status: Terminated
Initiated: 2009-12-09
Posted: 2010-04-23
Terminated: 2010-04-27
Recalling firm: Intervascular SAS
Product: InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries.
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: Packaging was mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: InterVascular SAS issued a "Recall Notification - Product Recall RC 020" notification dated January 29, 2009 to the sole consignee. The consignee had previously been notified by phone and all affected product had been segregated. For further information, contact InterVascular SAS at +33 442 08 77 84.
Quantity in commerce: 9
Distribution: Nationwide Distribution - Arizona.
Product codes and lots: Serial Number: 40246657, Lot number: 09M03.

Product code DSY

K964625Class IIHemapatch Vascular Patches, Intergard and Intergard-Rs Vascular ProsthesesIntervascular, Inc. / cleared 1997-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)