FDA recall Z-2453-2024

Angiodynamics, Inc. · Class II · device

Product

SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702

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

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-06-18
Report date
2024-08-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Queensbury, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2453-2024