DURAMAX STACKED TIP 28CM STR — Class II medical device recall Z-1769-2024
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-1769-2024 |
|---|---|
| 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 | 40 units |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 25051684011843 |
| Lot numbers | 5807204 |
Product
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028045
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-1769-2024. 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.