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U.S. Department of Health and Human Services

Class 2 Device Recall IsoLoc GasRelease Endorectal Baloon

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 Class 2 Device Recall IsoLoc GasRelease Endorectal Baloonsee related information
Date Initiated by FirmFebruary 04, 2025
Date PostedMarch 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1391-2025
Recall Event ID 96192
Product Classification Prostate immobilizer rectal balloon - Product Code PCT
ProductIsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Code Information UPN/Catalog Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694;
FEI Number 1319211
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information ContactKasey Newcomb
978-333-1108
Manufacturer Reason
for Recall		Product is mislabeled with the incorrect fill volume.
FDA Determined
Cause 2		Process control
ActionOn 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
Quantity in Commerce1,800 units
DistributionUS Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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