IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
FDA Recall #Z-2267-2024 — Class II — May 21, 2024
Product Description
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Reason for Recall
A single batch of ISO-100 IsoLoc Gas-Release Endorectal Balloons is mislabeled. The affected ISO-100 balloon catheter has a nominal fill volume of 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml).
Recalling Firm
Angiodynamics, Inc. — Queensbury, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,500 units (75 kits with 20 units per kit)
Distribution
US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.
Code Information
UPN/Catalog: ISO-100; UDI/DI: 10851546007100 (Box) and 00851546007103 (Pouch); Lot number: 5402.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated