Recalls / —

—#212288

Product

IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;

FDA product code

PCT — Prostate Immobilizer Rectal Balloon

Device class

Class 2

Medical specialty

Radiology

Affected lot / code info

UPN/Catalog Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694;

Why it was recalled

Product is mislabeled with the incorrect fill volume.

Root cause (FDA determination)

Process control

Action the firm took

On February 4, 2025, URGENT VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. ACTIONS TO BE TAKEN BY CONSIGNEES OF THE RECALL NOTIFICATION 1. IMMEDIATELY - Stop using the product subject to recall. - Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). - Segregate this product in a secure location for return to AngioDynamics, Inc. - Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. - Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return), following the directions on this page and the Reply Verification Tracking Form. * Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com * Fax Reply Verification Tracking Form: 1-855-273-0519 (Fax #) Attn: ISO-60 Recall Coordinator - Call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 6:00 p.m. EST (Monday Friday) to obtain a replacement or credit for your returned product. - Report any Adverse reactions or quality problems associated with recalled devices to US FDA via MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 3. Package and Return the Recalled Product. - Package any product that is being returned in an appropriate shipping box. - Write the RMA number (provided on the Recall Verification Tracking Form) on the RMA reference sticker and affix the sticker to the outside of the shipping box. - Contact AngioDynamics Inc. by phone or email (above contact) for shipping labels for returning the device. - Seal the box and return to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: ISO-60 Recall Coordinator

Recalling firm

Firm

Angiodynamics, Inc.

Address

603 Queensbury Ave, Queensbury, New York 12804-7619

Distribution

Distribution pattern

US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.

Timeline

Recall initiated

2025-02-04

Posted by FDA

2025-03-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #212288. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.