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.
FDA Recall Z-1913-2015 · Posted 2015-06-26
Recalling FirmVascutek, Ltd.
Recall StatusTerminated
Product CodeMAL
Date Initiated2015-05-15
Date Terminated2015-10-20
Product Quantity12
Reason for Recall
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.