medical MODERATE Updated 2024-08-07

Angiodynamics, Inc. recalls SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiog

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Recalled Product

SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701

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Hazard / Issue

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)

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UPN: H787107327015 UDI-DI: 25051684009772 (Box) 15051684009775 (Pouch) Lot Number: A0424031

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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