Recall Z-2267-2024— Angiodynamics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Angiodynamics, Inc., initiated 2024-05-21. FDA's recall record names no specific 510(k) clearance for this event. Product: IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100. 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 100cc/ml but the inner pouch identifies the product as an ISO-60 (fill volume of 60cc/ml)..
- Recalling firm
- Angiodynamics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-21
- Firm location
- Queensbury, NY, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.