Angiodynamics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1774-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 18, 2024

Date Posted: May 15, 2024

Recall Number: Z-1774-2024

Event ID: 94349

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.

Status: Ongoing

Product Quantity: 250 units

Code Information:

UDI-DI: 25051684025680 Lot Numbers: 5810278

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated