Reported Apr 24, 2013 · Terminated
Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of…
Elana, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elana, Inc. · 10480 Little Patuxent Pkwy · Columbia, MD · 21044-3568
Is this the product you have?
- 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.
- Lot codes and dates
Model 280S/N 776S/N 706S/N 758
- Amount recalled
- 3 devices
Where it was sold
Why it was recalled
Distribution of an unapproved device into interstate commerce.
This product could cause temporary or reversible health problems — stop using it.
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