Reported Mar 4, 2015 · Terminated
NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496005001131, REF/Catalog No. 600500113, STERILE, Rx ONLY --- For single…
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 H7496005001131, REF/Catalog No. 600500113, 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 4247589426925342713134310122434247343448224387486438883844148014419289443743944475794474969449187345049234534887453488845728054604160461223946240814640706464169046491504651400465512646609714662034466609246726884680286468290546903034697126469780447052504708240471269347214034731034474237347994794807935481068848140384814614
- Amount recalled
- 454 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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