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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 Gelsealsee related information
Date Initiated by FirmMay 15, 2015
Date PostedJune 26, 2015
Recall Status1 Terminated 3 on October 20, 2015
Recall NumberZ-1913-2015
Recall Event ID 71305
PMA NumberP890045 
Product Classification Graft, vascular, synthetic/biologic composite - Product Code MAL
ProductGelseal 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.
Code Information Product Code 433008, Batch 301509/02, Serial Numbers 0001515204, 0001515205, 0001515206, 0001515207, 0001515208, 0001515209, 0001515210, 0001515211, 0001515212, 0001515213, 0001515214, 0001515215
Recalling Firm/
Manufacturer		 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
ActionOn 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 Commerce12
DistributionDistributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = MAL
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