FDA
EXXCEL Soft Standard Wall EPTFE Vascular Graft;
D:8 mm: L: 50 mm straight
Maquet Cardiovascular LLS, 45 Barbour Pond Drive, Wayne, NJ 07470
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.
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.