Z-1912-2015Class II

Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to...

Name: Z-1912-2015 Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to...
Creator: Vascutek, Ltd.
Published: 2015-05-15
License: https://open.fda.gov/license/

Vascutek, Ltd. / initiated 2015-05-15 / Terminated / root cause: labeling and UDI

FDA source

Vascutek, Ltd. began a recall of Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or... on 2015-05-15. FDA classified it as Class II and gives the reason as "Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft". 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-1912-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-15
Posted: 2015-06-26
Terminated: 2015-10-20
Recalling firm: Vascutek, Ltd.
Product: Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Product code: MAL Graft, Vascular, Synthetic/Biologic Composite
Reason for recall: Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 5/15/2015, Vascutek issued a URGENT FIELD SAFETY NOTICE to their consignee informing them of the corrective action of the affected product. The information included details of the affected devices, including potential risks and actions to be taken by medical staff and distributors.
Quantity in commerce: 12
Distribution: Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Product codes and lots: Product Code 431508, Batch 301509/01, Serial Numbers 0001515180, 0001515181, 0001515182, 0001515183, 0001515184, 0001515185, 0001515186, 0001515187, 0001515188, 0001515189, 0001515190, 0001515191

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1912-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1912-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-26
Z-1913-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-26

Product code MAL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)