IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: IS...
FDA Recall #Z-1391-2025 — Class II — February 4, 2025
Product Description
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Reason for Recall
Product is mislabeled with the incorrect fill volume.
Recalling Firm
Angiodynamics, Inc. — Queensbury, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,800 units
Distribution
US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.
Code Information
UPN/Catalog Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated