DURAFLOW 2 — Class II medical device recall Z-1765-2024
Ongoing recall by Angiodynamics, Inc., reported 2024-05-15, distributed in VA. Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, pos
| Recall number | Z-1765-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics, Inc., Queensbury, NY, United States |
| Recall initiated | 2024-03-18 |
| Classified | 2024-05-03 |
| Reported by FDA | 2024-05-15 |
| Distributed | VA |
| Quantity | 65 units |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 25051684014837 |
| Lot numbers | 5807415 |
Product
DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
Reason for recall
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
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-1765-2024. 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.