Reported Mar 4, 2015 · Terminated
NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, 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, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 60070997, 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 42490774269176427929343095144344291435782043745824397278440880244136524417802443735644469354448734447576745054554508682453487645490324573232460397046127294613703462393046406964641242465006046500614654980466213346659144672429467243046803714682826469091046914294696900470441547129964722861473092247357344742076474207747511144764646477143147806054786234479812448088764812348481404648198114831349
- Amount recalled
- 602 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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