SOFT-VU KUMPE 5F X 65CM -Used for patients in need of recall: Labeling Error
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Why was SOFT-VU KUMPE 5F X 65CM -Used for patients in need of 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)
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UPN: H787107327015 UDI-DI: 25051684009772 (Box) 15051684009775 (Pouch) Lot Number: A0424031
- Product
- SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 595 boxes
- Distribution
- US Nationwide distribution.
- Recall date
- August 7, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)