FDA-Device2024-05-15Class II
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
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
250 units
Manufactured in
603 Queensbury Ave, N/A, Queensbury, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1774-2024Don't want to check this manually?
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