Device product
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Z-2267-2024
Product summary
- Event
- Event 94773
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,500 units (75 kits with 20 units per kit)
- Official record key
device-enforcement:Z-2267-2024
Official wording
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).
Code information: UPN/Catalog: ISO-100; UDI/DI: 10851546007100 (Box) and 00851546007103 (Pouch); Lot number: 5402.
Distribution pattern: US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.
Derived failure modes
-
Labeling or packaging
mislabeled