Reported Aug 7, 2024 · Ongoing
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Angiodynamics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Angiodynamics, Inc. · 603 Queensbury Ave · Queensbury, NY · 12804-7619
Is this the product you have?
- SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis
- Catalog Number10732701
- Lot codes and dates
- UPNH787107327015
- UDI-DI25051684009772 (Box) 15051684009775 (Pouch)
- Lot NumberA0424031
- Amount recalled
- 595 boxes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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)
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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