Home / Recalls / Angiodynamics, Inc. / Z-1760-2024

Z-1760-2024 Class II Ongoing

Recalled by Angiodynamics, Inc. — Queensbury, NY

Recall Details

Product Type: Devices
Report Date: May 15, 2024
Initiation Date: March 18, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 455 units

Product Description

DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015

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 Pattern

Code Information

UDI-DI: 25051684014738 Lot Numbers: 5807192, 5807197

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