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Angiodynamics, Inc. recalls SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Recalled August 7, 2024 · FDA recall Z-2454-2024 · Angiodynamics
Hazard
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length) · FDA Class II
Units
595 boxes
Sold at
US Nationwide distribution.
Description
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
Product
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Manufacturer(s)
Angiodynamics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →