FDA Device recall Z-0786-2016
Bard Distaflo Vascular Bypass Graft
- FDA Device
- Class II
- terminated
- Published 2016-02-17
On 2016-02-17 the FDA classified a Class II recall of Bard Distaflo Vascular Bypass Graft by Bard Peripheral Vascular, citing size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0786-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-05 |
| Published | 2016-02-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | AL, CA, TX |
Product
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Reason
Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Identifiers
| code_info | Product Code: DF8006SC Lot Number: VTZE1783 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0786-2016%22
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