Angiodynamics, Inc. 2024-08-07 Health serious FDA
Health · FDA · Recall #FDA-Z-2453-2024
SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog… Recall
Issued August 7, 2024 · Angiodynamics, Inc.
In August 2024, Angiodynamics, Inc. recalled the SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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)
What you should do
- 1 Stop using SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Angiodynamics, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Angiodynamics, Inc.
- Category
- Health
- Recall date
- August 7, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-2453-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Angiodynamics, Inc. has 9 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.