Device product
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Z-1391-2025
Product summary
- Event
- Event 96192
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,800 units
- Official record key
device-enforcement:Z-1391-2025
Official wording
Reason: Product is mislabeled with the incorrect fill volume.
Code information: UPN/Catalog Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694;
Distribution pattern: US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.
Derived failure modes
-
Labeling or packaging
mislabeled