Bard Distaflo Vascular Bypass Graft — Class II medical device recall Z-0785-2016
Terminated recall by Bard Peripheral Vascular Inc, reported 2016-02-17, distributed in AL, CA, TX. Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm gr
| Recall number | Z-0785-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2016-01-05 |
| Classified | 2016-02-09 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2016-03-25 |
| Distributed | AL, CA, TX |
| Quantity | 4 units |
| Reason classes | labeling |
| Lot numbers | VTZE1782 |
Product
Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Reason for recall
Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0785-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.