FDA-Device2025-03-26Class II
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Angiodynamics, Inc.
Hazard
Product is mislabeled with the incorrect fill volume.
Sold states
US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.
Affected count
1,800 units
Manufactured in
603 Queensbury Ave, N/A, Queensbury, NY, United States
Products
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1391-2025Don't want to check this manually?
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