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Terminated

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.

FDA Recall Z-1912-2015 · 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.

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