IsoLoc Short Profile Prostate Immobilization Treatment recall: Labeling Error
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Why was IsoLoc Short Profile Prostate Immobilization Treatment recalled?
Product is mislabeled with the incorrect fill volume.
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 Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694;
- Product
- IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 1,800 units
- Distribution
- US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.
- Recall date
- March 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)