Recall Z-2267-2024 ยท PCT Prostate Immobilizer Rectal Balloon
Angiodynamics, Inc.
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
| Date | Jul 3, 2024 (initiated May 21, 2024) |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | Under Investigation by 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. |
| Quantity | 1,500 units (75 kits with 20 units per kit) |
| Distribution | US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.