FDA Device recall Z-1771-2024
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheres…
- FDA Device
- Class II
- ongoing
- Published 2024-05-15
On 2024-05-15 the FDA classified a Class II recall of DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheres… by Angiodynamics, citing tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1771-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-18 |
| Published | 2024-05-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Angiodynamics |
| Distribution | VA |
Product
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191
Reason
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Identifiers
| code_info | UDI-DI: 25051684011850 Lot Numbers: 5807208 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1771-2024%22
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