Recall Z-2061-2010 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Maquet Cardiovascular, LLC
Hemashield Gold Woven Double Velour Vascular Branch Graft
| Date | Jul 22, 2010 (initiated May 24, 2010) |
| Status | Terminated |
| Reason | Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety. |
| Root cause | Package design/selection |
| Action | Letters were sent by Federal Express commencing July 12, 2010. Distribution has to be obtained from Boston Scientific. Questions are directed to the local Sales/Service Representative, or to the firm's Customer Service at 1-888-880-2874. |
| Quantity | xx |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012952 | HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT Boston Scientific/Medi-Tech, Oct 2, 2001 |