Angiodynamics, Inc. recalls IsoLoc Prostate Immobilization Treatment Balloon Device Kit,
See all recalls from Angiodynamics, Inc. →Recalled Product
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Hazard / Issue
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).
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: UPN/Catalog: ISO-100; UDI/DI: 10851546007100 (Box) and 00851546007103 (Pouch); Lot number: 5402.
✅ 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.
Looking for a safe alternative?
Search Amazon for IsoLoc Prostate Immobilization Treatment →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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