FDA Enforcement
Class II
Ongoing
SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Recall: Z-2453-2024
·
Reported August 7, 2024
Enforcement
- Recall Number
- Z-2453-2024
- Event ID
- 94903
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Angiodynamics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 7, 2024
- Initiation Date
- June 18, 2024
- Classification Date
- July 31, 2024
- Address
- 603 Queensbury Ave, N/A, Queensbury, NY, 12804-7619, United States
Description
SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
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 Info
UPN: H787107327025 UDI-DI: 25051684009789 (Box) 15051684009782 (Pouch) Lot Number: A0424035
Distribution
US Nationwide distribution.
Quantity
519 boxes