Recall Z-2454-2024— Angiodynamics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Angiodynamics, Inc., initiated 2024-06-18. It names one FDA 510(k) clearance: K173762. Product: SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701. 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).
- Recalling firm
- Angiodynamics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-18
- Firm location
- Queensbury, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.