FDA-Device2024-05-15Class II
DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
Angiodynamics, Inc.
Hazard
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Sold states
VA
Affected count
65 units
Manufactured in
603 Queensbury Ave, N/A, Queensbury, NY, United States
Products
DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1765-2024Don't want to check this manually?
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