Z-2454-2024 Class II Ongoing
FDA device recall Z-2454-2024 was initiated by Angiodynamics, Inc. on Jun 18, 2024 and is designated Class II. 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) The recall status is ongoing. Affected quantity: 595 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 7, 2024
- Initiation Date
- Jun 18, 2024
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2454-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026