SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Reported: August 7, 2024 Initiated: June 18, 2024 #Z-2453-2024
Product Description
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)
Details
- Recalling Firm
- Angiodynamics, Inc.
- Units Affected
- 519 boxes
- Distribution
- US Nationwide distribution.
- Location
- Queensbury, NY
Frequently Asked Questions
What product was recalled? ▼
SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702. Recalled by Angiodynamics, Inc.. Units affected: 519 boxes.
Why was this product recalled? ▼
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)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2024. Severity: Moderate. Recall number: Z-2453-2024.
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