Reported Mar 4, 2015 · Terminated
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935, 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 H749600309351, REF/Catalog No. 60030935, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588
- Product UsageNAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems
- Lot codes and dates
Lots 4244449425161642713414298367433298543444194384598440679844192844435205444406844469904474943449977445054464547470457286645728674604183461290246232774623278463828446431684650003465078746620924662093466675946693304675594468956746971474706860470991247131174718988472136447272364741949474814047511024760883476858847794304788780479808248213204824164
- Amount recalled
- 1355 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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