Class II
Medical Device Recall: SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Angiodynamics, Inc. · June 18, 2024
Reason for Recall
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)
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
519 boxes
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2453-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.