BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Te...
FDA Recall #Z-1774-2024 — Class II — March 18, 2024
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
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
250 units
Distribution
VA
Code Information
UDI-DI: 25051684025680 Lot Numbers: 5810278
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated