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U.S. Department of Health and Human Services

Class 2 Device Recall Gelseal

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  Class 2 Device Recall Gelseal see related information
Date Initiated by Firm May 15, 2015
Date Posted June 26, 2015
Recall Status1 Terminated 3 on October 20, 2015
Recall Number Z-1912-2015
Recall Event ID 71305
PMA Number P890045 
Product Classification Graft, vascular, synthetic/biologic composite - Product Code MAL
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.
Code Information Product Code 431508, Batch 301509/01, Serial Numbers 0001515180, 0001515181, 0001515182, 0001515183, 0001515184, 0001515185, 0001515186, 0001515187, 0001515188, 0001515189, 0001515190, 0001515191
Recalling Firm/
Vascutek, Ltd.
Newmains Avenue
Inchinnan United Kingdom
Manufacturer Reason
for Recall
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = MAL and Original Applicant = CARBOMEDICS, INC.