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U.S. Department of Health and Human Services

Class 2 Device Recall IsoLoc GasRelease Endorectal Balloon

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 Class 2 Device Recall IsoLoc GasRelease Endorectal Balloonsee related information
Date Initiated by FirmMay 21, 2024
Date PostedJuly 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2267-2024
Recall Event ID 94773
Product Classification Prostate immobilizer rectal balloon - Product Code PCT
ProductIsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Code Information UPN/Catalog: ISO-100; UDI/DI: 10851546007100 (Box) and 00851546007103 (Pouch); Lot number: 5402.
FEI Number 1319211
Recalling Firm/
Manufacturer		 Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619
For Additional Information ContactDavid Greer
518-795-1676
Manufacturer 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).
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce1,500 units (75 kits with 20 units per kit)
DistributionUS Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, 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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