Recall Z-1593-2011 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Maquet Cardiovascular, LLC
Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
| Date | Mar 7, 2011 (initiated Dec 7, 2010) |
| Status | Terminated |
| Reason | One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed. |
| Root cause | Other |
| Action | The firm, Maquet, contacted their sole consignee/customer via telephone informing the customer of the recall and instructing the customer to put the unit to the side. On December 8, 2010 a sales representative visited the site to ensure the unit had been put to the side and to ensure the unit was shipped back to Maquet. If you have any questions, call the Manager, Regulator Affairs at 973-709-7487. |
| Quantity | one unit |
| Distribution | Nationwide distribution: SC only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962342 | HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH Meadox Medicals, Div. Boston Scientific Corp., Sep 10, 1996 |