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IsoLoc
RADIADYNE, L.L.C. · Model ISO-100 · UDI-DI 00851546007103
PCT
Prescription
5
510(k) clearances
1
Adverse events
2
Recalls
7
Facilities
Description
IsoLoc Prostate Immobilization Treatment Balloon Device Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-04 | Angiodynamics, Inc. | Product is mislabeled with the incorrect fill volume. |
| 2024-05-21 | Angiodynamics, Inc. | 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 iden |
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