IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Summary
The FDA issued a Class II for IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-10 by Angiodynamics, Inc.. Reason: 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 10.
Details
Source
Device Recall
External ID
Z-2267-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
Product Description
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Lot/Code Info: UPN/Catalog: ISO-100; UDI/DI: 10851546007100 (Box) and 00851546007103 (Pouch); Lot number: 5402.
Quantity Affected: 1,500 units (75 kits with 20 units per kit)
Reason for Recall
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).
Distribution
US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-21
Company
Queensbury, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Angiodynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Angiodynamics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Angiodynamics, Inc. have FDA actions?
Angiodynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2267-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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