Class II

Medical Device Recall: IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100

Angiodynamics, Inc. · May 21, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

1,500 units (75 kits with 20 units per kit)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2267-2024

Status: ongoing

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