SOFT-VU KUMPE Catheters Recalled for Mislabeled Inner Pouch
Angiodynamics is recalling SOFT-VU KUMPE 5F X 65CM angiographic catheters (595 boxes nationwide) because inner pouch labels may show information for a different catheter model while shelf-box labels are correct.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a labeling discrepancy that could cause misuse, but no actual harm has been documented.
Plain-English summary
Angiodynamics, Inc. is recalling SOFT-VU KUMPE 5F X 65CM catheters, which are used for angiographic diagnosis. The recall affects 595 boxes distributed nationwide.
The issue is mislabeling of the inner pouch. While the shelf-box labeling correctly identifies the product and catheter length, the inner pouch label may contain information for a different catheter model with a different length. This discrepancy could lead healthcare providers to select or use an incorrect catheter length.
Healthcare providers and facilities with affected units should verify inner pouch labeling before use. Products with conflicting or questionable labeling should not be used. Contact Angiodynamics, Inc. for instructions regarding affected product disposition.
The recalled product
- Product
- SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- mis-labeling
Distribution
Distributed nationwide across the United States.
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