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.
- Recall Initiated
- May 15, 2015
- Posted
- June 26, 2015
- Terminated
- October 20, 2015
- Recall Number
- Z-1912-2015
- Quantity
- 12
Reason for Recall
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Distribution
Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Lot / Code Info
Product Code 431508, Batch 301509/01, Serial Numbers 0001515180, 0001515181, 0001515182, 0001515183, 0001515184, 0001515185, 0001515186, 0001515187, 0001515188, 0001515189, 0001515190, 0001515191
Root Cause
Error in labeling
Action Taken
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.
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