Z-1391-2025 Class II Ongoing
FDA device recall Z-1391-2025 was initiated by Angiodynamics, Inc. on February 4, 2025 and is designated Class II. Reason for recall: Product is mislabeled with the incorrect fill volume. The recall status is ongoing. Affected quantity: 1,800 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,800 units
Product Description
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Reason for Recall
Product is mislabeled with the incorrect fill volume.
Distribution Pattern
US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.
Code Information
UPN/Catalog Number: ISO-60; UDI-DI: 00851546007219; Batch/Lot No.: 5694;