Vascutek, Ltd.: Medical Device Recall in 2015 - (Recall #: Z-1913-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Gelseal Straight Diameter 8mm Length 30cm. 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 Classification:

Class II

Date Initiated: May 15, 2015

Date Posted: July 8, 2015

Recall Number: Z-1913-2015

Event ID: 71305

Reason for Recall:

Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.

Status: Terminated

Product Quantity: 12

Code Information:

Product Code 433008, Batch 301509/02, Serial Numbers 0001515204, 0001515205, 0001515206, 0001515207, 0001515208, 0001515209, 0001515210, 0001515211, 0001515212, 0001515213, 0001515214, 0001515215

Distribution Pattern:

Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.

Voluntary or Mandated:

Voluntary: Firm initiated