Angiodynamics, Inc. recalls IsoLoc Short Profile Prostate Immobilization Treatment Ballo
See all recalls from Angiodynamics, Inc. →Recalled Product
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Hazard / Issue
Product is mislabeled with the incorrect fill volume.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: UPN/Catalog Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694;
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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