Recall Z-2267-2024
Angiodynamics, Inc. · initiated May 21, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Codes / lots: UPN/Catalog: ISO-100; UDI/DI: 10851546007100 (Box) and 00851546007103 (Pouch); Lot number: 5402.
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: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2267-2024
- Initiated
- May 21, 2024
- Posted by FDA
- July 3, 2024
- Product code
- PCT – Prostate Immobilizer Rectal Balloon
- 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.
- Recalling firm
- Angiodynamics, Inc., Queensbury, NY