Recall Z-1391-2025 ยท PCT Prostate Immobilizer Rectal Balloon
Angiodynamics, Inc.
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
| Date | Mar 18, 2025 (initiated Feb 4, 2025) |
| Status | Open, Classified |
| Reason | Product is mislabeled with the incorrect fill volume. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 1,800 units |
| Distribution | US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.