FDA-Device2024-08-07Class II
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Angiodynamics, Inc.
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)
Sold states
US Nationwide distribution.
Affected count
595 boxes
Manufactured in
603 Queensbury Ave, N/A, Queensbury, NY, United States
Products
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2454-2024Don't want to check this manually?
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