Z-2454-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2024
- Initiation Date
- June 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 595 boxes
Product Description
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Reason for Recall
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)
Distribution Pattern
US Nationwide distribution.
Code Information
UPN: H787107327015 UDI-DI: 25051684009772 (Box) 15051684009775 (Pouch) Lot Number: A0424031