Recall Z-1913-2015 ยท MAL Graft, Vascular, Synthetic/Biologic Composite
Vascutek, Ltd.
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.
| Date | Jun 26, 2015 (initiated May 15, 2015) |
| Status | Terminated |
| Reason | Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. |
| Root cause | 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 | 12 |
| Distribution | Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.