Reported Mar 4, 2015 · Terminated
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 60232234, STERILE, Rx ONLY --- For single use…
Navilyst Medical, 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: Navilyst Medical, Inc · 10 Glens Falls Technical Park · Glens Falls, NY · 12801
Is this the product you have?
- NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 60232234, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
- Lot codes and dates
Lots 4264873428629442883704306895438710944164514426311445197244874864499675450102445259684616390461938846230734655776465783646598294669429467508046923224739538474979747693684774274477775348190494828035
- Amount recalled
- 61 units
This recall covers 60 products
The agency filed one notice per product. You are reading one of them; the other 59 are below.
47 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection.
This product could cause temporary or reversible health problems — stop using it.
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