Recall Z-0786-2016 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Bard Peripheral Vascular Inc
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
| Date | Feb 9, 2016 (initiated Jan 5, 2016) |
| Status | Terminated |
| Reason | Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft. |
| Root cause | Error in labeling |
| Action | Customer notification letters were sent on 01/05/2016. Customers were asked to not use the affected product, or further distribute it. Customers were asked to check all inventory locations for the affected product code, lot number combination listed. If customers further distributed any of the product they are requested to contact that location, advise them of the recall, and forward the listed instructions. The letter states to remove all identified product from the shelves. If no affected product is going to be returned the firm states to complete and return the attached form statin |
| Quantity | 4 units |
| Distribution | Distributed in the states of AL, TX, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983861 | DISTAFLO BYPASS GRAFT Impra, Inc., Nov 24, 1998 |