Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2453-2024 — SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702

U.S. FDA — Device Enforcement · United States · 2024-06-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2453-2024
Date of alert
2024-06-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Angiodynamics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
25051684009789
Reported risk: 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)
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.