FDA-Device2024-07-10Class II
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Angiodynamics, Inc.
Hazard
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).
Sold states
US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.
Affected count
1,500 units (75 kits with 20 units per kit)
Manufactured in
603 Queensbury Ave, N/A, Queensbury, NY, United States
Products
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2267-2024Don't want to check this manually?
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