Reported Jul 10, 2024 · Ongoing
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Angiodynamics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Angiodynamics, Inc. · 603 Queensbury Ave · Queensbury, NY · 12804-7619
Is this the product you have?
- IsoLoc Prostate Immobilization Treatment Balloon Device Kit
- Catalog/UPNISO-100
- Lot codes and dates
- UPN/CatalogISO-100
- UDI/DI10851546007100 (Box) and 00851546007103 (Pouch)
- Lot number5402
- Amount recalled
- 1,500 units (75 kits with 20 units per kit)
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Angiodynamics, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.