DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascul...
FDA Recall #Z-1767-2024 — Class II — March 18, 2024
Product Description
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028035
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.
Recalling Firm
Angiodynamics, Inc. — Queensbury, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
555 units
Distribution
VA
Code Information
UDI-DI: 25051684011836 Lot Numbers: 5807194, 5809616, 5809462
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated