Angiodynamics recalls IsoLoc Prostate Immobilization Balloon Kit (ISO-100) due to mislabeling causing potential wrong size use. Affected units have specific lot numbers and UDI codes.
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).
Angi: The IsoLoc Prostate Immobilization Balloon Kit (ISO-100) was recalled because a batch of balloons is mislabeled as ISO-60 instead of ISO-100. This could lead to incorrect sizing during medical procedures, potentially causing complications.
The balloons are mislabeled as ISO-60 (60cc/ml) instead of ISO-100 (100cc/ml). This could result in incorrect sizing during prostate procedures, potentially causing complications like tissue damage or ineffective treatment.
Patients using the IsoLoc Prostate Immobilization Balloon Kit for medical procedures are affected. Those with the specific lot number 5402 or UDI codes 10851546007100 (box) and 00851546007103 (pouch) are most at risk.
Check the box UDI code (10851546007100) and pouch UDI code (00851546007103) for the affected batch. The lot number is 5402 for this specific mislabeled batch.
Verify the box UDI code (10851546007100) and pouch UDI code (00851546007103) to confirm if the product is affected.
The affected lot number is 5402.
Check the box UDI code (10851546007100) and pouch UDI code (00851546007103) for the affected batch.
The recall does not specify a remedy, so contact Angiodynamics directly for guidance.
We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.
Subject: Recall Z-2267-2024 — Angiodynamics Angiodynamics Hello, I own a Angiodynamics that is covered by recall Z-2267-2024 from Angiodynamics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
