FDAFDA · Food and drugs·Recall number Z-1550-2013
IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System. Indicated for palliative treatment of biliary strictures produced by malignant neoplasms
Published June 26, 2013 · Recall initiated: May 29, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There was an error on the outer labeling of this device. The inner label was correct.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- IDEV Technologies, Inc.
- Distributor
- Nationwide Distribution to the states of FL, NY, and PA.
- Lot
- Model Number: S-05-100-120-G3; Lot Number 01049037
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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