FDAFDA · Food and drugs·Recall number Z-1143-2013
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
Published April 24, 2013 · Recall initiated: February 14, 2013
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
Distribution of an unapproved device into interstate commerce.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elana, Inc.
- Distributor
- Distributed in the states of Pennsylvania, Texas, and New York.
- Lot
- Model 280, S/N 776, S/N 706, S/N 758
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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