FDA-Device2024-05-15Class II
DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
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
188 units
Manufactured in
603 Queensbury Ave, N/A, Queensbury, NY, United States
Products
DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1763-2024Don't want to check this manually?
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