# FDA recall Z-1774-2024

> **Angiodynamics, Inc.** · Class II · device recall initiated 2024-03-18.

## Product

BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit-	Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.  	  Product Number: H965103038181

## 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.

## Distribution

VA

## Key facts

- **Recall number:** Z-1774-2024
- **Recalling firm:** Angiodynamics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-18
- **Report date:** 2024-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Queensbury, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1774-2024

## Citation

> AI Analytics. FDA recall Z-1774-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1774-2024. Source: US FDA. Licensed CC0.

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