IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Reported: July 10, 2024 Initiated: May 21, 2024 #Z-2267-2024
Product Description
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
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).
Details
- Recalling Firm
- Angiodynamics, Inc.
- Units Affected
- 1,500 units (75 kits with 20 units per kit)
- Distribution
- US Nationwide distribution in the states of AZ, FL, IL, MO, MS, NJ, NM, NY, PA, TX, WI.
- Location
- Queensbury, NY
Frequently Asked Questions
What product was recalled? ▼
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100. Recalled by Angiodynamics, Inc.. Units affected: 1,500 units (75 kits with 20 units per kit).
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2024. Severity: Moderate. Recall number: Z-2267-2024.
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