FDA recall Z-2267-2024

Angiodynamics, Inc. · Class II · device

Product

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).

Distribution

US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.

Key facts

Status: Ongoing
Initiation date: 2024-05-21
Report date: 2024-07-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Queensbury, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2267-2024