Device product
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Z-2454-2024
Product summary
- Event
- Event 94903
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 595 boxes
- Official record key
device-enforcement:Z-2454-2024
Official wording
Reason: 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)
Code information: UPN: H787107327015 UDI-DI: 25051684009772 (Box) 15051684009775 (Pouch) Lot Number: A0424031
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
Mislabeled