Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100

FDA Recall Z-2267-2024 · Posted 2024-07-03

Recalling FirmAngiodynamics, Inc.
Recall StatusOpen, Classified
Product CodePCT
Date Initiated2024-05-21
Product Quantity1,500 units (75 kits with 20 units per kit)

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).

Firm Action

On May 21, 2024 URGENT VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: IMMEDIATELY: 1. Stop using the product subject to recall. 2. Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). 3. Segregate this product in a secure location for return to AngioDynamics, Inc. 4. Forward a copy of this recall notification to all sites to which you have distributed affected product.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑