Recall Z-0866-2010 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Maquet Cardiovascular, LLC
EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470
| Date | Feb 26, 2010 (initiated Jan 20, 2010) |
| Status | Terminated |
| Reason | Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall Vascular Grafts, lot # 12633379 were mislabeled as Exxcel Soft Standard Wall Grafts. Bleeding could occur if wrong product is used. |
| Root cause | Labeling mix-ups |
| Action | Recall letters were sent to all US customers on January 20, 2010 by certified mail. Letters for foreign consignees were to be sent as soon as translation was completed. Customer are directed to call the company at 973-709-7515 for more information. |
| Quantity | 18 units |
| Distribution | Product was distributed to hospitals in TX, TN, CT, AR, AZ as well as to Austria and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052964 | EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN Boston Scientific Corp, Jan 6, 2006 |