FDA-Device2024-05-15Class II
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041
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
30 units
Manufactured in
603 Queensbury Ave, N/A, Queensbury, NY, United States
Products
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1768-2024Don't want to check this manually?
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