IsoLoc Prostate Immobilization Treatment Balloon Device recall: Labeling Error
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Why was IsoLoc Prostate Immobilization Treatment Balloon Device recalled?
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).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UPN/Catalog: ISO-100; UDI/DI: 10851546007100 (Box) and 00851546007103 (Pouch); Lot number: 5402.
- Product
- IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
- Recalling firm
- Angiodynamics, Inc.
- 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.
- Recall date
- July 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)