FDA Recall
Terminated
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.
Recall: Z-1913-2015
·
Initiated May 15, 2015
Recall
- Recall Number
- Z-1913-2015
- Event Number
- 71305
- Firm
- Vascutek, Ltd. Newmains Avenue Inchinnan United Kingdom
- FEI Number
- 3002808437
- Product Code
- MAL
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- May 15, 2015
- Posted
- June 26, 2015
- Terminated
- October 20, 2015
Description
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.
Reason
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
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.
Distribution
Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
Quantity
12